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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