Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015532525

FEI Number

3015532525

Entity Name

CARESTREAM HEALTH, INC.

City/State/Country

Rochester, NY, US

Establishment Address

882 Linden Ave., Rochester, NY 14625, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

SPY Lymphatics Kit with SPY AGENT GREEN SPY Lymphatics Pack with SPY AGENT GREEN SPY Minimally Invasive Surgery Pack with SPY AGENT GREEN SPY Minimally Invasive Surgery Kit with SPY AGENT GREEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-02-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-02-28
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2020-02-28

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
1317267	Carestream Health, Inc.	Rochester, NY, US
3029911	Carestream Health, Inc.	WHITE CITY, OR, US
3005778458	CARESTREAM HEALTH, INC., GLOBAL R&D CENTER	SHANGHAI, CN
3003578745	Rayco (Xiamen) Medical Products Company Limited	XIAMEN Fujian, CN
1317307	Carestream Health, Inc	Rochester, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

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3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
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1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015532525. Last updated year: 2026. Please use registration number 3015532525 when referencing this establishment in official correspondence.