What is FDA product code PTZ?

This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › DiagnosticColposcope (And Colpomicroscope), Exempt

Cerviray

Name: Cerviray
Brand: Cerviray

The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically…

Registry build 21.09.26

The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically consists of an illuminated lens and video camera unit connected to an LCD touch screen display. During use, Cerviray is used with the speculum(not provided) to keep a certain distance to obtain good quality of image and prevent direct contact with patient. The Cradle is also included for charging purpose only.

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Guangxi (1).

Chinese manufacturers registered for FDA product code PTZ
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Zumax Medical Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Alltion (Guangxi) Instrument Co., Ltd.	Wuzhou	Guangxi	Manufacturer	8
Shenzhen Goldcare Meditech Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2

Record

Regulatory record for Cerviray
Listed by	Aidot
FDA product code	PTZ
Device type	Colposcope (And Colpomicroscope), Exempt
Device class	Class 2
Regulation	21 CFR 884.1630
Premarket notification	Exempt
Record published	2023-06-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 10 to 75 °C; Storage environment temperature -20 to 70 °C; Handling environment humidity 30 to 75 % RH; Storage environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal
Packaging	Box of 2
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Cerviray
Catalogue number	Size	Status
ADT-CC10		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Optomic	Optomic España SA	5
UHD series Video Colposcope	Edan Instruments, Inc.	4
zumax	Zumax Medical Co., Ltd.	2
Atmos	Atmos Medizintechnik Gmbh & Co. KG	2
Video Colposcope	Edan Instruments, Inc.	1
Light guide	Olympus Medical Systems Corp.	1
Colposcope OCS-500 Digital Camera Adapter	Olympus Medical Systems Corp.	1
Colposcope OCS-500 System Rack	Olympus Medical Systems Corp.	1
Small tray	Olympus Medical Systems Corp.	1
Liger Medical	Liger Medical	1
Eyepiece shape TV mount	Olympus Medical Systems Corp.	1

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.