← Back to Medical Device Explorer

CARESTREAM HEALTH INC

DRX-EVOLUTION · Radiology

510(k): 6 Recall: 6 UDI: 29 MAUDE: 10 Class.: 60

510(k) Clearances (6)

DRX-Evolution Plus System

2024-03-12

Substantially Equivalent

DRX-Evolution with Carestream Digital Tomosynthesis

2019-12-20

Substantially Equivalent

DRX-Evolution/Plus with Dual Energy

2019-11-04

Substantially Equivalent

Carestream DRX-Evolution

2016-12-13

Substantially Equivalent

DRX-EVOLUTION

2015-03-11

Substantially Equivalent

DRX-EVOLUTION, MODEL VX3733-SYS

2009-07-20

Substantially Equivalent

Recalls (6)

CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

2015-08-07

Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/b

2013-11-25

Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/

2013-11-25

Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky t

2013-11-25

Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main componen

2013-08-20

Carestream received a report of an exposure being initiated without a patient image captured. The patient was imaged 2 times before an image was captured. The field engineer who visited the site reported the system allowed an exposure without the assignment of a bucky or image receptor.

Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

2013-06-03

Due to potential for an x-ray exposure technique change.

UDI Registrations (29)

DRX-Evolution Plus System

DRX-Evolution Plus System (B-PCSH-P-X)

CARESTREAM DRX-EVOLUTION

80KW GENERATOR/FOR DRX-EVOLUTION

DRX-Evolution Plus System

DRX-EVOLUTION Plus - CSH WS w SLIM E-BOX

DRX-Evolution Plus System

Elevating Table - DRX Evo Plus

CARESTREAM DRX-EVOLUTION Plus

DRX-EVOLUTION PLUS SYSTEM L1741040

DRX-Evolution Plus System

FIBRE GRID DRX-EVO WALL 180CM10:1 40LPCM

DRX-Evolution Plus System

DRX EVO FIXD ELE TBL MDL VX3733-TAB

DRX-Evolution Plus System

DRX-Evolution Plus Transbay OTC System

CARESTREAM DRX-EVOLUTION

MOVEABLE TABLE FOR DR SYS

DRX-Evolution Plus System

DRX-Evolution Plus System (P-PCSCH-X-X)

DRX-Evolution Plus System

DRX-EVOLUTN PREMIUM CSH WS W/ SLIM E-BOX

CARESTREAM DRX-EVOLUTION Plus

DRX-EVOLUTION PLUS SYSTEM LOSHPD

CARESTREAM DRX-EVOLUTION

DRX-EVOLUTION/P-PCSH-P-X

DRX-Evolution Plus System

DRX-Evolution Plus Automatic - Dual Buck

CARESTREAM DRX-EVOLUTION

DRX-EVOLUTION/B-BCSH-P-X

CARESTREAM DRX-EVOLUTION

DRX-EVO 65 kW GENERATOR STANDARD/Q

CARESTREAM DRX-EVOLUTION

DRX-EVO 80 kW GENERATOR STANDARD/Q

CARESTREAM DRX-EVOLUTION

CARESTREAM DRX BABIX HOLDER

CARESTREAM DRX-EVOLUTION

DRX-EVOLUTION/P-PCSH-P-X W/INWP

CARESTREAM DRX-EVOLUTION

DRX-EVOLUTION/P-PCSH-P-X W/WP

CARESTREAM DRX-EVOLUTION

DRX-EVOLUTION/P-PCSH-P-X

DRX-Evolution Plus System

Elevating Table (320) - DRX Evo Plus

DRX-Evolution Plus System

DRX-EVO MOTOR CSH WS ONLY/X-PCSH4343-X-X

CARESTREAM DRX-EVOLUTION Plus

DRX-EVOLUTION PLUS SYSTEM L1739192

CARESTREAM DRX-EVOLUTION

ASSM-UNIVERSAL GRID HOLDER, DRX-EVOLUTIO

CARESTREAM DRX-EVOLUTION Plus

DRX-EVOLUTION PLUS SYSTEM L1739218

CARESTREAM DRX-EVOLUTION Plus

DRX-EVOLUTION PLUS SYSTEM L1741032

CARESTREAM DRX-EVOLUTION

GRID/DRX-EVO WALL 140CM 8:1/40 LN/CM

DRX-Evolution Plus System

DRX-Evolution Plus System (P-X-P-X)

MAUDE Adverse Events (10)

Malfunction

20240216

Injury

20240129

Malfunction

20231120

Malfunction

20230830

Injury

20230723

Injury

20230112

Injury

20220629

Malfunction

20211221

Injury

20200722

Injury

20101209

FDA Classification (60)

Processor, Cine Film

Radiology

Hydrogel Spacer

Radiology

Cassette, Measurement, Ardran-Crooks

Radiology

Assembly, Tube Housing, X-Ray, Therapeutic

Radiology

Generator, Orthovoltage, Therapeutic X-Ray

Radiology

Cabinet, X-Ray System

Radiology

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

Camera, Multi Format, Radiological

Radiology

System, Imaging, Holography, Acoustic

Radiology

Film, Radiographic

Radiology

Counter, Whole Body, Nuclear

Radiology

Holder, Syringe, Lead

Radiology

Processor, Radiographic-Film, Automatic, Dental

Radiology

Camera, X-Ray, Fluorographic, Cine Or Spot

Radiology

System, Therapeutic, X-Ray

Radiology

Display, Diagnostic Radiology

Radiology

Radiation Therapy Marking Device

Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

Radiology

System, Nuclear Magnetic Resonance Imaging

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Analyzer, Medical Image

Radiology

Dosimeter, Ionizing Radiation, Implanted

Radiology

Solid State Fluoroscopic X-Ray Imager

Radiology

Processor, Radiographic-Film, Automatic

Radiology

Test-Pattern, Radiographic

Radiology

Densitometer, Bone

Radiology

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Radiology

Radiological Software Device To Predict Future Breast Cancer Risk

Radiology

Device, Beam Limiting, X-Ray, Diagnostic

Radiology

Prostate Immobilizer Rectal Balloon

Radiology

Device, Communications, Images, Ophthalmic

Radiology

System, X-Ray, Mammographic

Radiology

Chair, Pneumoencephalographic

Radiology

Phantom, Anthropomorphic, Radiographic

Radiology

Changer, Radiographic Film/Cassette

Radiology

System, Applicator, Radionuclide, Remote-Controlled

Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Radiology

Needle, Isotope, Gold, Titanium, Platinum

Radiology

Shield, Gonadal

Radiology

Source, Teletherapy, Radionuclide

Radiology

System, Image Processing, Radiological

Radiology

Arthrogram Tray

Radiology

Tube Mount, X-Ray, Diagnostic

Radiology

Device, Digital Image Storage, Radiological

Radiology

Post Breast Biopsy Hemostatic Breast Compression Device

Radiology

Collimator, Low Voltage, Therapeutic X-Ray

Radiology

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology

Source, Isotope, Sealed, Gold, Titanium, Platinum

Radiology

Table, Radiologic

Radiology

System, Applicator, Radionuclide, Manual

Radiology

Programmer, Changer, Film/Cassette, Radiographic

Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Radiology

Holder, Radiographic Cassette, Wall-Mounted

Radiology

Radiographic Contrast Tray

Radiology

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

Automated Radiological Image Processing Software

Radiology

System, Imaging, X-Ray, Electrostatic

Radiology

Coil, Magnetic Resonance, Specialty

Radiology

Device, Spot-Film

Radiology