Image 1

F3 IMAGE 1 Camera Head NTSC, f = 16.8 mm

Registry build 21.09.26
8manufacturers in China registered for this device type
8catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FET
Manufacturer City Province Registered as Device types
Qisda Electronics (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Shenzhen Hugemed Medical Technical Development Co., Ltd. Shenzhen Guangdong Manufacturer 22
Scivita Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 19
Guangzhou RED Pine Medical Instrument Co., Ltd. Guangzhou Guangdong Manufacturer 8
Zhuhai Pusen Medical Technology Co., Ltd. Zhuhai Guangdong Manufacturer 7
Shanghai Seegen Photoelectric Technology Co., Ltd. Shanghai Shanghai Manufacturer 7
Shenzhen Sophway Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3

Record

Regulatory record for Image 1
Listed by Karl Storz GmbH & Co. KG
FDA product code FET
Device type Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device class Class 2
Regulation 21 CFR 876.1500
Record published 2016-09-23
Record revised 2024-08-19 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide, Peracetic Acid, Hydrogen Peroxide
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Image 1
Catalogue number Size Status
22220056-3 In distribution
22220060-3 In distribution
TH111 In distribution
TH110 In distribution
TH100 In distribution
22220133-3 In distribution
22260131-3 In distribution
22220131-3 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Endocam Richard Wolf Gmbh 21
Endoscopic Video Imaging System/Component, Gastroenterology-Urology Karl Storz GmbH & Co. KG 20
Gimmi Gimmi Gmbh 9
Exalt™ Boston Scientific Corporation 8
Conmed ConMed Corporation 7
Video Adapter Olympus Medical Systems Corp. 6
EleVision™ Schölly Fiberoptic GmbH 6
Evis Exera Colonovideoscope Olympus Medical Systems Corp. 5
Water Resistant CAP Olympus Medical Systems Corp. 5
CystoView™ Verathon Medical (Canada) ULC 5
Riwo Richard Wolf Gmbh 5
Video Processor Pentax of America, Inc. 5

Showing 12 of 105. All products under Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer