Carestream Health, Inc

FDA Filings

This page includes the latest FDA filings for Carestream Health, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Carestream Health, Inc.
DRX-Evolution/Plus With Dual Energy2019-11-04
Carestream Health, Inc.
Carestream DRX-1 System With DRX Plus 2530 Detectors2019-02-08
Carestream Health, Inc
Eclipse II2018-06-21
Carestream Health, Inc.
SmartGrid2018-04-13
Carestream Health, Inc.
DRX-Revolution Nano Mobile X-ray System2018-02-05
Carestream Health, Inc.
OnSight 3D Extremity System2018-01-19
Carestream Health, Inc.
Carestream DRX-Evolution2016-12-13
CARESTREAM HEALTH, INC.
Carestream DRX-1 System With DRX Plus 4343 Detectors2015-11-25
Carestream Health, Inc.
Carestream DRX-1 System2015-06-24
CARESTREAM HEALTH,INC.
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR2013-06-07
CARESTREAM HEALTH,INC.
CS 12002011-11-10
CARESTREAM HEALTH, INC.
CS 76002011-09-23
CARESTREAM HEALTH, INC.
KODAK 1500 INTRAORAL CAMERA2009-08-18
CARESTREAM HEALTH, INC.
DRX-EVOLUTION, MODEL VX3733-SYS2009-07-20
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 SYSTEM2009-04-06

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Elite CR System
CARESTREAM HEALTH, INC.2019-11-25
Classic CR System
CARESTREAM HEALTH, INC.2019-11-25
DIRECTVIEW CR Long-Length Imaging System
CARESTREAM HEALTH, INC.2019-11-25
DRX 2530C DETECTOR
CARESTREAM HEALTH, INC.2019-11-25
Max CR System
CARESTREAM HEALTH, INC.2019-11-25
DRX 2530C DETECTOR
CARESTREAM HEALTH, INC.2019-11-25
Elite CR System
CARESTREAM HEALTH, INC.2019-11-25
Medical X-ray Green / MXG Film
CARESTREAM HEALTH, INC.2019-11-04
Q-FDR-VW-T
CARESTREAM HEALTH, INC.2019-10-25
Q-FDR-VW-R
CARESTREAM HEALTH, INC.2019-10-25
Q-FDR-VW-L
CARESTREAM HEALTH, INC.2019-10-25
Medical X-ray Green / MXG Film
CARESTREAM HEALTH, INC.2019-10-24
DRYVIEW DVB Laser Imaging Film
CARESTREAM HEALTH, INC.2019-10-24
Oncology EDR2 Film
CARESTREAM HEALTH, INC.2019-05-13
4343R Digital Image Receptor
CARESTREAM HEALTH, INC.2019-05-07
DRX-Transportable System
CARESTREAM HEALTH, INC.2019-05-07
DRX-Transportable System
CARESTREAM HEALTH, INC.2019-05-07
CARESTREAM DRX-1 System
CARESTREAM HEALTH, INC.2019-05-07
DRX-Transportable System
CARESTREAM HEALTH, INC.2019-05-07
DRX-Evolution Plus System
CARESTREAM HEALTH, INC.2019-05-07
TRIMAX 4343FC Detector
CARESTREAM HEALTH, INC.2019-05-07
TRIMAX 4343F Detector
CARESTREAM HEALTH, INC.2019-05-07
TRIMAX 4343C Detector
CARESTREAM HEALTH, INC.2019-05-07
TRIMAX 4343 Detector
CARESTREAM HEALTH, INC.2019-05-07
TRIMAX 3543C Detector
CARESTREAM HEALTH, INC.2019-05-07
TRIMAX 3543 Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Core 4343FC Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Core 4343F Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Core 4343C Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Core 4343 Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Core 3543C Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Core 3543 Detector
CARESTREAM HEALTH, INC.2019-05-07
DRX Plus 4343FC DETECTOR
CARESTREAM HEALTH, INC.2019-05-07
DRX Plus 4343F DETECTOR
CARESTREAM HEALTH, INC.2019-05-07
DRX Plus 4343C DETECTOR
CARESTREAM HEALTH, INC.2019-05-07

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