BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carestream Health, Inc

    Reg #: 1317307 · FEI: 1317307 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    77
    Establishment Types
    4
    Classifications
    13

    Registration Details

    Registration Name
    Carestream Health, Inc
    Registration Number
    1317307
    FEI Number
    1317307
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1049 West Ridge Road
    City
    Rochester
    State
    NY
    ZIP
    14615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160723
    PMA Number
    P080018

    Owner / Operator

    Firm Name
    Carestream Health, Inc.
    Operator Number
    9097221
    Address
    150 Verona Street
    City
    Rochester
    State
    NY
    Postal Code
    14608
    Country
    US
    Correspondent
    Alyssa J Haig

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    Cassette, Radiographic Film IXA
    Chair, Adjustable, Mechanical INN
    Film, Radiographic IWZ
    Stool, Operating-Room FZM
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL
    Full Field Digital, System, X-Ray, Mammographic MUE
    System, X-Ray, Stationary KPR
    System, Image Processing, Radiological LLZ
    Grid, Radiographic IXJ
    Screen, Intensifying, Radiographic EAM
    Table, Radiographic, Non-Tilting, Powered IZZ

    Proprietary Names

    OnSight 3D Extremity System CR Cassettes for Vita Systems Carestream CR Cassettes Patient Chair 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 Step Box Foot and Ankle Step Focus HD 43 Detector Lux HD 2530 Detector (Lux HD 2530) DRX-Revolution Mobile X-ray System Lux HD 35 Detector (Lux HD 35) Lux HD 43 Detector (Lux HD 43) DRX-LC Detector CARESTREAM DRX-1 System CARESTREAM DRX-MOBILE RETROFIT KIT CARESTREAM DRX-TRANSPORTABLE SYSTEM CARESTREAM DRX-TRANSPORTABLE SYSTEM/FLEX DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen DIRECTVIEW CR Mammography Feature CARESTREAM CR Mammography Cassette with EHR-M3 Screen Lux HD 43 Detector CARESTREAM DRX-EVOLUTION PLUS DRX-Compass X-ray System Lux HD 35 Detector DR-FIT X-ray System DRX Plus 2530C Detector Focus HD 35 Detector DRX-Revolution Nano Mobile X-ray System DRX Plus 3543 Detector DRX Plus 3543C Detector DRX Core 3543 Detector DRX Core 3543C Detector TRIMAX 3543C Detector TRIMAX 3543 Detector LUX 35 Detector Focus 35C Detector TRIMAX 35C Detector DIRECTVIEW CR LONG-LENGTH IMAGING SYSTEM DIRECTVIEW CR Long Length Cassette with PQ Screen DIRECTVIEW CR Cassette with PQ Screen DIRECTVIEW CR Long Length Portable Cassette with PQ Screen DIRECTVIEW CR CASSETTES Carestream Image Suite DIRECTVIEW CR Long Length Portable Grid Flexible Phosphor Screen GP2 Trimax 4343C Detector DRX Plus 4343 Detector Trimax 4343FC Detector Trimax 4343 Detector DRX Core 4343C Detector DRX Core 4343F Detector Trimax 4343F Detector DRX Core 4343 Detector DRX Plus 4343C Detector DRX Plus 4343F Detector DRX Core 4343FC Detector DRX Plus 4343FC Detector Focus 43C Detector TRIMAX 43C Detector QT-740 QT-750

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198