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Sources: EU EUDAMED, US FDA
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Country: Japan
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RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
FDA Enforcement
Class II
·Terminated·Eizo Corporation·July 22, 2015
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JAPAN OPTICAL CO.,LTD.
Manufacturer
🇯🇵 Japan
MASAHIRO MARUYAMA Inc.
Manufacturer
🇯🇵 Japan
NIDEK.CO.Ltd.,
Manufacturer
🇯🇵 Japan·27 Basic UDI-DIs·61 Devices·10 Importers
NIKON-ESSILOR CO., LTD.
Manufacturer
🇯🇵 Japan
OKAMOTO INDUSTRIES, INC. Ibaraki Plant
Manufacturer
🇯🇵 Japan·2 Importers
Menicon Co., Ltd.
Manufacturer
🇯🇵 Japan·4 Importers
NABTESCO CORPORATION ACCESSIBILITY INNOVATIONS COMPANY
Manufacturer
🇯🇵 Japan·1 Importer
EYEVAN Inc.
Manufacturer
🇯🇵 Japan·30 Basic UDI-DIs·1910 Devices·1 Importer
MATSUDA EYEWEAR JAPAN LLC
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·575 Devices·1 Importer
Sagami Rubber Industries Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·26 Devices
GE Healthcare Japan Corporation
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·8 Devices
CYBERDYNE Inc.
Manufacturer
🇯🇵 Japan·TÜV Rheinland LGA Products GmbH
iLAND solutions Co. Ltd.
Manufacturer
🇯🇵 Japan
Hitachi High-Tech Corporation
Manufacturer
🇯🇵 Japan·118 Basic UDI-DIs·288 Devices·1 Importer
Hitachi, Ltd.
Manufacturer
🇯🇵 Japan·21 Basic UDI-DIs·24 Devices·3 Importers
ADSTEC Corporation
Manufacturer
🇯🇵 Japan
Senko Medical Instrument Mfg. Co., Ltd.
Manufacturer
🇯🇵 Japan·1 Importer
Denka Co., Ltd.
Manufacturer
🇯🇵 Japan·5 Basic UDI-DIs·9 Devices·1 Importer