SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)
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
- 00810035220492 ()
- Indirect flat panel x-ray detector
No Description
RADMEDIX, LLC
1
In Commercial Distribution
- 00810035220478 ()
- Indirect flat panel x-ray detector
DR10FW Wireless Digital Flat Panel Detector_LTF
iRay Group
DR10FW
In Commercial Distribution
- 06970569091020 ()
- Indirect flat panel x-ray detector
Mano2530F clearance depends on Luna1012X by LTF
iRay Group
Mano2530F
In Commercial Distribution
- 06970569090986 ()
- Indirect flat panel x-ray detector
Mano2530A clearance depends on Luna1012X by LTF
iRay Group
Mano2530A
In Commercial Distribution
- 06970569090979 ()
- Indirect flat panel x-ray detector
Mano4343F clearance depends on Mars1717X by LTF
iRay Group
Mano4343F
In Commercial Distribution
- 06970569090962 ()
- Indirect flat panel x-ray detector
Mano4336A clearance depends on Mars1717X by LTF
iRay Group
Mano4343A
In Commercial Distribution
- 06970569090955 ()
- Indirect flat panel x-ray detector
Mano4336F clearance depends on Mars1417X by LTF
iRay Group
Mano4336F
In Commercial Distribution
- 06970569090948 ()
- Indirect flat panel x-ray detector
Mano4336A clearance depends on Mars1417X by LTF
iRay Group
Mano4336A
In Commercial Distribution
- 06970569090931 ()
- Indirect flat panel x-ray detector
Mars1417X(19 pin) wireless digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
iRay Group
Mars1417X
In Commercial Distribution
- 06970569090887 ()
- Indirect flat panel x-ray detector