Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1317267

FEI Number

1317267

Entity Name

Carestream Health, Inc.

City/State/Country

Rochester, NY, US

Establishment Address

1669 Lake Avenue, Rochester, NY 14652, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Carestream Health, Inc. (Owner Number: 9097221)

Owner / Operator Contact Address

150 Verona Street, Rochester, NY 14608, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

T-MAT G/RA X-OMAT 2 Dental Duplicating DRYVIEW DVB+ Laser Imaging Film DRYVIEW DVM+ Mammography Laser Imaging Film Ultra-speed DRYVIEW DVB+ Premium Laser Imaging Film DRYVIEW DVE Laser Imaging Film INSIGHT AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN) AMV AERMEI AMV Laser Imaging Film 125SH 28X35CM (11X14IN) AMV GBX Fixer and Replenisher GBX Developer and Replenisher AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV AERMEI AMV Laser Imaging Film 125SH 35X43CM (14X17IN) AMV Rapid Access Twin Pack READYPRO Twin Pack TRIMAX TXM Laser Imaging Film DRYVIEW DVM Mammography Laser Imaging Film SD-SM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2006-06-01

Official Correspondent

Alyssa Haig

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carestream Health, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3029911	Carestream Health, Inc.	WHITE CITY, OR, US
3005778458	CARESTREAM HEALTH, INC., GLOBAL R&D CENTER	SHANGHAI, CN
3015532525	CARESTREAM HEALTH, INC.	Rochester, NY, US
3003578745	Rayco (Xiamen) Medical Products Company Limited	XIAMEN Fujian, CN
1317307	Carestream Health, Inc	Rochester, NY, US

Similar Registrations

Registration Number	Establishment Name	Location
3015509619	DURR DENTAL SE	Bietigheim-Bissingen Baden-Wurttemberg, DE
3013602093	ON POINT MEDICALS GMBH	Klagenfurt Karnten, AT
3016170492	SHANGHAI ALWINGS MEDICAL INSTRUMENT CO.,LTD.	Shanghai, CN
1317307	Carestream Health, Inc	Rochester, NY, US
3012187973	JERSEY DENTAL SUPPLIES	Lakewood, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1317267. Last updated year: 2026. Please use registration number 1317267 when referencing this establishment in official correspondence.