Who else makes this device?

Name: NON-Mydriatic Auto Fundus Camera
Brand: NON-Mydriatic Auto Fundus Camera

Ophthalmic › DiagnosticCamera, Ophthalmic, Ac-Powered

NON-Mydriatic Auto Fundus Camera

The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for…

Registry build 21.09.26

The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.

3manufacturers in China registered for this device type

1catalogue number

9510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code HKI
Manufacturer	City	Province	Registered as	Device types
Shanghai Mediworks Precision Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	13
Taizhou City K&W International Trade Co., Ltd.	Jiangyan	Jiangsu	Repacker / relabeller	38
Chongqing BIO Newvision Medical Equipment Ltd.	Chongqing	Chongqing	Manufacturer	2

Record

Regulatory record for NON-Mydriatic Auto Fundus Camera
Listed by	Nidek Incorporated, United States
FDA product code	HKI
Device type	Camera, Ophthalmic, Ac-Powered
Device class	Class 2
Regulation	21 CFR 886.1120
Establishment	Specification developer, Manufacturer
Record published	2016-06-24
Record revised	2018-09-24 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for NON-Mydriatic Auto Fundus Camera
Catalogue number	Size	Status
AFC-330		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Jedmed	Jedmed Instrument Company	15
Neolight	Neolight, LLC	11
Natus	Xltek	6
RetCam Envision	Natus Medical Denmark ApS	6
3nethra	Forus Health Pvt.ltd.,	6
iCam	Optovue, Inc.	5
iFusion	Optovue, Inc.	5
Canon Inc.	Canon Inc.	4
Camera, Ophthalmic, Ac-Powered	Chongqing Kanghuaruiming S&T Co., Ltd..	4
3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2)	Topcon Corp.	3
Retinal Camera TRC-50DX	Topcon Corp.	3
NON-Mydriatic Retinal Camera TRC-NW400	Topcon Corp.	2

Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190198	2019-04-01
K152729	2016-06-06
K113451	2012-05-08
K070231	2007-04-24
K061768	2006-09-28
K023719	2002-12-23
K014274	2002-04-17
K973533	1997-11-04
K973218	1997-11-04

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-06-16	Class II	Device Design	Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.	185 cameras	2015-03-03
2013-08-01	Class II	Software design	Under certain circumstances, the Left eye image may be saved as the Right eye image.	86	2014-02-25

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.