International Medical Devices Database

Manufacturer Address
Konica Medical Imaging, Inc., 411 Newark Pompton Tpke, Wayne NJ 07470-6657
Source
USFDA
2 Events
- Recall of Konica Minolta
- Recall of Device Recall Regius

2 devices in the database

Konica Minolta

Model / Serial
Emulsion''s numbers( X=any number): X742, X842, X152, and X023.
Product Classification
Radiology Devices
Device Class
1
Implanted device?
No
Distribution
The firm distributed the duplicating firm to 960 imaging locations, clinics, and hospitals nationwide. There are 5 VA medical centers located in VA, RI, WI, NH, and TN.
Product Description
Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only.

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.

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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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Konica Medical Imaging, Inc.

2 devices in the database

Konica Minolta

Device Recall Regius