International Medical Devices Database

Manufacturer Address
Brainlab AG, Kapellenstr. 12, Feldkirchen Germany
Manufacturer Parent Company (2017)
Brainlab AG
Source
USFDA
4 Events

4 devices in the database

Brainlab AG

Model / Serial
Potentially affected are Patient Data Manager versions 2.0.0, 2.0.1, 2.0.2, 2.0.3, 2.1.0. Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: Main model/catalogue numbers: 25121-01 PATIENT DATA MANAGER 2.0.0 LICENSE ONLY 25100-05 PATIENT DATA MANAGER 2.0.1 LICENSE ONLY 25100-06 PATIENT DATA MANAGER 2.0.2 LICENSE ONLY 25100-07 PATIENT DATA MANAGER 2.0.3 LICENSE ONLY 25100-08 Further the above listed main-articles are incorporated into the following model/catalogue numbers: 15600 MULTI-TOUCH INFORMATION GATEWAY 15610 IN-WALL MULTI-TOUCH INFORMATION GATEWAY 15700 CURVE CEILING-MOUNTED DUAL DISPLAY 15705 CURVE CEILING-MOUNTED SINGLE DISPLAY 15709-10 CURVE CM COMPUTER UNIT 18070 KICK NAVIGATION STATION 18071 KICK MONITOR CART 18071-19 KICK MONITOR CART BASE (WITH OS) 18073-17 KICK MCU (WITH OS) 18077 KICK UPGRADE NAVIGATION STATION 18078 KICK NAVIGATION STATION (REFURB. CAMERA) 18080 KICK NAVIGATION STATION 18080-01 KICK NAVIGATION STATION BRAZIL 18080-02 KICK NAVIGATION STATION CHINA 18081 KICK DPS MONITOR CART 18081-19 KICK DPS MONITOR CART BASE (WITH OS) 18083-17 KICK DPS MCU (WITH OS) 18090 KICK EM NAVIGATION STATION 19900 CURVE DUAL DISPLAY NAVIGATION STATION 19900-04B MONITOR CART-CURVE DUAL DISPL. SPAREPART 19900-04C MONITOR CART-CURVE DUAL DISPL. SPAREPART 19905 CURVE SINGLE DISPLAY NAVIGATION STATION 19905-04B MONITOR CART-CURVE SINGLE DISP SPAREPART 22216 CRANIAL NAVIGATION SW 3.0 22217 ENT NAVIGATION SW 3.0 22241 NAVIGATION SW ENT EM 1.0 22241-01 NAVIGATION SW ENT EM 1.0 - FOR BENELUX 22244 NAV SW ENT EM 1.0 ADD-ON FOR OPT NAV 22245 NAV SW ENT OPTICAL ADDON FOR ENT EM NAV 22267 SPINE & TRAUMA 3D (VER. 2.1) 25100C PATIENT BROWSER AND CONTENT MANAGER 25100D PATIENT BROWSER AND CONTENT MANAGER 25110 BRAINLAB SESSION SHARING NURSE STATION 25121 PATIENT BROWSER AND CONTENT MANAGER 26201-12A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201-36A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201-60A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26201A ORIGIN DATA MANAGEMENT SUBSCRIPTION 26243A UPGRADE TO ORIGIN DATA MANAGEMENT 26269-12A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269-36A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269-60A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26269A ORIGIN DATA MANAGEMENT SUBSCRIPTION FOC 26282 UPGRADE TO ORIGIN DATA MANAGEMENT FOC 26290 ELEMENTS PLANNING SUITE FOR NAVIGATION 26291 ELEMENTS PLANNING SUITE FOR BUZZ 27001 NAVIGATION SOFTWARE KNEE 3 27003 NAVIGATION SOFTWARE KNEE 3 BASE SOFTWARE 27004 UPG NAVIGATION SOFTWARE KNEE 3 BASE SW 27006 UPG NAVIGATION SOFTWARE KNEE 3 BASE SW 27007 NAVIGATION SOFTWARE KNEE3 UNIVERSAL 30038A ORIGIN DATA MANAGEMENT 30039 ORIGIN DATA MANAGEMENT ORTHO 70346 UPD PATIENT BROWSER&CONTENT; MANAGER 2.X 70349 UPD PACKAGE PDM 1.X TO 2.X INCL ELEMENTS 71201 UPG TO NAV SW CRAN 3.0 FROM CRAN 2.X 71202 UPG TO CRANIAL NAV SW 3.0 FROM ANY PREV 71202 UPG TO CRANIAL NAV SW 3.0 FROM ANY PREV 71203 UPG TO NAV SW ENT 3.0 FROM ENT 2.X 71204 UPG TO ENT NAV SW 3.0 FROM ANY PREV E15600 MULTI-TOUCH INFORMATION GATEWAY E15709-10 CURVE CM COMPUTER UNIT E18073-17 KICK MCU (WITH OS) E19900 CURVE DUAL DISPLAY NAVIGATION STATION E19900-04B MONITOR CART-CURVE DUAL DISPL. SPAREPART E19900-04C MONITOR CART-CURVE DUAL DISPL. SPAREPART E19900-05 MONITOR CART-CURVE BYPASS 2 DISP SPARE E19905 CURVE SINGLE DISPLAY NAVIGATION STATION E19905-04B MONITOR CART-CURVE SINGLE DISP SPAREPART E19905-05 MONITOR CART-CURVE BYPASS 1 DISP SPARE
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.
Product Description
Digital Lightbox, BrainLAB system, image processing, radiological || Product Usage: || The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

Device Recall Brainlab AG ExacTrac Vero

Model / Serial
Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version. Model/catalogue numbers: 20892 EXACTRAC VERO SOFTWARE 3.5 20892A EXACTRAC VERO SOFTWARE 3.5.1 20892B EXACTRAC VERO SOFTWARE 3.5.2 20892C EXACTRAC VERO SOFTWARE 3.5.3 20893 VERO INFRARED POSITIONING/MONITORING SW 46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1 46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC 46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46228 EXACTRAC VERO 3.5 ROW 46238 EXACTRAC VERO 3.5 JAPAN
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
Product Description
ExacTrac Vero is a Patient Positioning System for Radiation therapy.

Device Recall Brainlab AG

Model / Serial
Adaptive Hybrid Surgery Analysis version 1.0.0 Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE 21703-02 ELEMENTS ADAPT HYB SURG ANALYSIS INST 21702 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-12 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-36 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-60 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21703 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-12 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-36 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-60 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21713 ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS 21722 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-12 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-36 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-60 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21723 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-12 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-36 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-60 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21732 ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
Product Description
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

Device Recall Brainlab AG

Model / Serial
Brain Metastases version 1.0.0 Model/catalogue number Description 21702-04 ELEMENTS AUT. BRAIN METASTASES PLAN INST 21703-01 ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE 21703-02 ELEMENTS ADAPT HYB SURG ANALYSIS INST 21702 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-12 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-36 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21702-60 ELEMENTS AUTOMATIC BRAIN METS PLAN SUB 21703 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-12 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-36 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21703-60 ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR 21713 ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS 21722 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-12 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-36 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21722-60 ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC 21723 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-12 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-36 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21723-60 ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC 21732 ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
Product Description
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

40 manufacturers with a similar name

Learn more about the data here

Brainlab AG

Manufacturer Parent Company (2017)
Brainlab AG
Source
NIDFSINVIMA

Brainlab Ag

Manufacturer Parent Company (2017)
Brainlab AG
Source
NIDFSINVIMA

Brainlab AG.

Manufacturer Parent Company (2017)
Brainlab AG
Source
NIDFSINVIMA

Brainlab Sales Gmbh || Brainlab Ag

Manufacturer Parent Company (2017)
Brainlab AG
Source
NIDFSINVIMA

Brainlab AG

Manufacturer Parent Company (2017)
Brainlab AG
Source
LAANSM

35 more

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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