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Devices
Device Recall Regius
Model / Serial
Serial # 0729-0005
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Texas
Product Description
Regius Model 370 Digital Radiography || Konica Minolta
Manufacturer
Konica Minolta Medical Imaging USA, Inc.
1 Event
Recall of Device Recall Regius
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Manufacturer
Konica Minolta Medical Imaging USA, Inc.
Manufacturer Address
Konica Minolta Medical Imaging USA, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
Source
USFDA
2 devices with a similar name
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Device Recall Regius
Model / Serial
All serial numbers.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
These units have been distributed to hospitals and clinics nationwide.
Product Description
Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software.
Manufacturer
Konica Medical Imaging, Inc.
Device Recall REGIUS IM, RIM
Model / Serial
58 units distributed between June 2003 and January 2006. Software version prior to January 31, 2006.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
The units were distributed to hospitals nationwide through the firm''s sales force and resellers. There are no government accounts.
Product Description
REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technologist review and audit. Key processing for specialized exams, totally automated processing for hands off operation. Centralized workflow device for dispersed readers environments. HIS/RIS patient status updates. Demographic Correction.
Manufacturer
Konica Minolta Medical Imaging USA, Inc.
Language
English
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