Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AY-DETECTOR, COMPLETE, DRX 1-C
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000160 ()
AB3753

  • Indirect flat panel x-ray detector
AY-DETECTOR, COMPLETE, DRX-1
CARESTREAM HEALTH, INC.
DRX-1 Detector
In Commercial Distribution

  • 60889974000153 ()
AB3752

  • Indirect flat panel x-ray detector
AY-DETECTOR-PACKED-25X30
CARESTREAM HEALTH, INC.
DRX 2530C DETECTOR
In Commercial Distribution

  • 60889974000078 ()
9J2791

  • Indirect flat panel x-ray detector
FOCUS HD 43 DETECTOR PACK ROK
CARESTREAM HEALTH, INC.
Focus HD 43 Detector
In Commercial Distribution

  • 60889975950617 ()
AL4713

  • Indirect flat panel x-ray detector
FOCUS HD 35 DETECTOR PACK ROK
CARESTREAM HEALTH, INC.
Focus HD 35 Detector
In Commercial Distribution

  • 60889975950600 ()
AL4712

  • Indirect flat panel x-ray detector
PACKED, LUX 35 DETECTOR, 3543
CARESTREAM HEALTH, INC.
Lux 35 Detector
In Commercial Distribution

  • 60889975950570 ()
AK7294

  • Indirect flat panel x-ray detector
PACKED, 4343C DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343C DETECTOR
In Commercial Distribution

  • 60889975950563 ()
AL6764

  • Indirect flat panel x-ray detector
PACKED, 4343 DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343 DETECTOR
In Commercial Distribution

  • 60889975950556 ()
AL6759

  • Indirect flat panel x-ray detector
PACKED, 3543C DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 3543C Detector
In Commercial Distribution

  • 60889975950549 ()
AL6755

  • Indirect flat panel x-ray detector
PACKED, 3543 DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 3543 Detector
In Commercial Distribution

  • 60889975950532 ()
AL6750

  • Indirect flat panel x-ray detector
PACKED, 2530C DETECTOR, DRX CORE 2
CARESTREAM HEALTH, INC.
DRX 2530C Detector
Not in Commercial Distribution

  • 60889975950525 ()
AG4322

  • Indirect flat panel x-ray detector
PACKED, DETECTOR, 2530 C
CARESTREAM HEALTH, INC.
DRX Plus 2530C Detector
In Commercial Distribution

  • 60889975950419 ()
AH9482

  • Indirect flat panel x-ray detector
AY-DETECTOR, PACKED, 4343FC, TRIMAX
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343FC
In Commercial Distribution

  • 60889974160239 ()
AE4207

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,4343F
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343F
In Commercial Distribution

  • 60889974160222 ()
AE4206

  • Indirect flat panel x-ray detector
AY-DETECTOR, PACKED, 4343C, TRIMAX
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343C
In Commercial Distribution

  • 60889974160215 ()
AE4205

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,4343
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,4343
In Commercial Distribution

  • 60889974160208 ()
AE4204

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,3543C
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,3543C
In Commercial Distribution

  • 60889974160192 ()
AE4201

  • Indirect flat panel x-ray detector
DETECTOR,PACKED,TRIMAX,3543
CARESTREAM HEALTH, INC.
DETECTOR,PACKED,TRIMAX,3543
In Commercial Distribution

  • 60889974160185 ()
AE4200

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343FC
CARESTREAM HEALTH, INC.
DRX Core 4343FC Detector
In Commercial Distribution

  • 60889974008517 ()
AD8205

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343F
CARESTREAM HEALTH, INC.
DRX Core 4343F Detector
In Commercial Distribution

  • 60889974008500 ()
AD8204

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343C
CARESTREAM HEALTH, INC.
DRX Core 4343C Detector
In Commercial Distribution

  • 60889974008494 ()
AD8203

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 4343
CARESTREAM HEALTH, INC.
DRX Core 4343 Detector
In Commercial Distribution

  • 60889974008487 ()
AD8202

  • Indirect flat panel x-ray detector
AY-PACKED, DRX CORE, 3543C
CARESTREAM HEALTH, INC.
DRX Core 3543C Detector
In Commercial Distribution

  • 60889974008470 ()
AD8201

  • Indirect flat panel x-ray detector
Assembly-PACKED, DRX CORE, 3543
CARESTREAM HEALTH, INC.
DRX Core 3543 Detector
In Commercial Distribution

  • 60889974008463 ()
AD8200

  • Indirect flat panel x-ray detector
AY-PACKED, 4343FC DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343FC DETECTOR
In Commercial Distribution

  • 60889974007541 ()
AD4403

  • Indirect flat panel x-ray detector
AY-PACKED, 4343F DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343F DETECTOR
In Commercial Distribution

  • 60889974007534 ()
AD4402

  • Indirect flat panel x-ray detector
AY-PACKED, 4343C DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343C DETECTOR
In Commercial Distribution

  • 60889974007527 ()
AD4401

  • Indirect flat panel x-ray detector
AY-PACKED, 4343 DETECTOR, DRX PLUS
CARESTREAM HEALTH, INC.
DRX Plus 4343 DETECTOR
In Commercial Distribution

  • 60889974007510 ()
AD4400

  • Indirect flat panel x-ray detector
AY-PKD-DRX-1C DETECTOR-CHINA
CARESTREAM HEALTH, INC.
DRX-1C Detector
In Commercial Distribution

  • 60889974000801 ()
AB5213

  • Indirect flat panel x-ray detector
AY-DETECTOR-2530-COMPLETE-OEM
CARESTREAM HEALTH, INC.
DRX 2530C DETECTOR
In Commercial Distribution

  • 60889974000795 ()
AB0710

  • Indirect flat panel x-ray detector
Elevating Table (320) - DRX Evo Plus
CARESTREAM HEALTH, INC.
DRX-Evolution Plus System
In Commercial Distribution

  • 60889971739247 ()
1739242

  • Indirect flat panel x-ray detector
TDR 3543C DETECTOR / FOR DIRECTVIEW SW
CARESTREAM HEALTH, INC.
TDR 3543C Detector
In Commercial Distribution

  • 60889971067326 ()
1067321

  • Indirect flat panel x-ray detector
QRAD DRX REFRESHED CONSOLE W/WP
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971039187 ()
1039189

  • Indirect flat panel x-ray detector
DRX-1 SYS CONSOLE ONLY W/DRX-1 SYS SW
CARESTREAM HEALTH, INC.
CARESTREAM DRX-1 System
In Commercial Distribution

  • 60889971035158 ()
1035153

  • Indirect flat panel x-ray detector
XRpad2 is a lightweight, cassette-sized flat panel detector for digital radiography.
VAREX IMAGING CORPORATION
3025 HWC-M
In Commercial Distribution

  • 00810751030078 ()


  • Indirect flat panel x-ray detector
The Varex Imaging XRpad 4343 F MED is a lightweight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 18.7 million pixel image matrix, a best-in-class 100 um pixel pitch, and a direct deposited CsI scintillator, the XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.
VAREX IMAGING WEST, LLC
4343 F MED
In Commercial Distribution


  • Width: 460 Millimeter
  • Weight: 4.1 Kilogram
  • Depth: 15 Millimeter
  • Length: 460 Millimeter
95510935-02

  • Indirect flat panel x-ray detector
XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
4336 HWC-M
In Commercial Distribution


  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 384 Millimeter
  • Weight: 3.2 Kilogram
95510981

  • Indirect flat panel x-ray detector
XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 3025 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
3025 HWC-M
In Commercial Distribution


  • Depth: 15.5 Millimeter
  • Length: 332 Millimeter
  • Width: 282 Millimeter
  • Weight: 1.8 Kilogram
95510991

  • Indirect flat panel x-ray detector
XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4343 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4343 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
VAREX IMAGING WEST, LLC
4343 HWC-M
In Commercial Distribution

  • 00810751030009 ()

  • Depth: 15.5 Millimeter
  • Length: 460 Millimeter
  • Width: 460 Millimeter
  • Weight: 3.8 Kilogram
95510607

  • Indirect flat panel x-ray detector
AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panels. The customer selects one of the following digital x-ray receptor panels: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717 G4. The solid state imaging receptors can be used in wireless or tethered configuration. The indications for use remain unchanged: Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammography. So the only difference between this submission and the predicate submission is the available selection of (previously cleared) digital panels. Each system consists of the following items: Customer supplies: Diagnostic x-ray generator (HF) Class I Code IZO. + Tubehead: Class I Code ITV + Tube Mount: Class I Code IYB + Attached Collimator, Manual (IZX) Class II 510(k) Exempt We supply: Digital X-Ray Receptor Panel 892.1680 Class II Code MQB. Digital X-ray Software 892.2050 Class II Code LLZ. The software offered for sale with this system has received previous 510(k) clearance in K210919. We are supplying rebranded versions of the reference devices coupled with the AccuVue software cleared in our predicate K210919.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220508 ()


  • Indirect flat panel x-ray detector
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