Carestream Health, Inc.
Carestream Health, Inc. holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2025, with 86 FDA device recalls on record.
Top product codes for Carestream Health, Inc.
FDA recalls by Carestream Health, Inc.
10 most recent of 86- Z-0437-2024 — DRX Revolution Mobile X-Ray System
- Z-0289-2024 — The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
- Z-1206-2023 — DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
- Z-0806-2020 — Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console.
- Z-1207-2019 — OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over.
- Z-2651-2017 — DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
- Z-1138-2017 — Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
- Z-1052-2017 — Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Z-2217-2016 — Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body
- Z-1594-2016 — CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Carestream Health, Inc.
- K251168 — Image Suite
- K241505 — DRX-Revolution Mobile X-ray System
- K233381 — DRX-Evolution Plus System
- K223842 — DRX - Compass
- K213307 — Eclipse II with Smart Noise Cancellation
- K202441 — Eclipse II with Smart Noise Cancellation
- K201373 — DRX-Compass
- K192894 — Vita Flex CR System with LLI
- K193574 — Q-Rad System
- K191879 — DRX-Evolution with Carestream Digital Tomosynthesis
- K190330 — DRX-Evolution/Plus with Dual Energy
- K191025 — DRX-Revolution Mobile X-ray System
- K183245 — Carestream DRX-1 System with DRX Plus 2530 Detectors
- K183474 — Carestream DRX-1 System with DRX Core Detectors
- K180809 — Eclipse II
- K180667 — SmartGrid
- K173924 — DRX-Revolution Nano Mobile X-ray System
- K173478 — OnSight 3D Extremity System
- K170755 — DRX-Revolution Nano Mobile X-ray System
- K170580 — Carestream Vue PACS
- K163203 — Carestream DRX-Evolution
- K160723 — OnSight 3D Extremity System
- K153103 — CARESTREAM Vue PACS
- K152467 — Touch Ultrasound
- K153142 — Carestream DRX-1 System with DRX Plus 4343 Detectors
- K151774 — CARESTREAM Vue Motion
- K150766 — Carestream DRX-1 System
- K150342 — Touch Ultrasound
- K141837 — DRX-EVOLUTION
- K140271 — TABLET VIEWER SOFTWARE FOR IMAGE SUITE
- K133442 — BONE SUPPRESSION SOFTWARE
- K132824 — CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
- K130567 — DR LONG LENGTH IMAGING SOFTWARE
- K130464 — CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
- K122523 — CARESTREAM VUE PACS
- K120246 — KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
- K120062 — DRX-REVOLUTION MOBILE X-RAY SYSTEM
- K111423 — CS 1600 INTRAORAL CAMERA
- K112321 — CS 1200
- K110919 — CARESTREAM PACS
- K111566 — DRYVIEW CHROMA IMAGING SYSTEM
- K111649 — CS 7600
- K091186 — KODAK 1500 INTRAORAL CAMERA
- K091889 — DRX-EVOLUTION, MODEL VX3733-SYS
- K090469 — CARESTREAM DRYVIEW 5850 LASER IMAGER
- K090318 — CARESTREAM DRX-1 SYSTEM
- K083673 — CARESTREAM PACS, MODEL CARESTREAM PACS VII
- K081836 — CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.