SEARCH RESULTS FOR: gs1(3663 results)
SW KT 9735898 STEALTHVIZ W DTI S8 EU-E
MEDTRONIC NAVIGATION, INC.
9735898
In Commercial Distribution
- 00763000456658 ()
- Neurological stereotactic surgery system
SFW KIT 9735898 STEALTHVIZ W DTI S8
MEDTRONIC NAVIGATION, INC.
9735898
In Commercial Distribution
- 00763000456641 ()
- Neurological stereotactic surgery system
SIZE 25 LEG, GLENOID TARGETER
ARTHREX, INC.
AR-5400-25
In Commercial Distribution
- 00888867315525 ()
AR-5400-25
- Orthopaedic prosthesis implantation positioning instrument, reusable
SIZE 24 LEG, GLENOID TARGETER
ARTHREX, INC.
AR-5400-24
In Commercial Distribution
- 00888867315518 ()
AR-5400-24
- Orthopaedic prosthesis implantation positioning instrument, reusable
SIZE 22 LEG, GLENOID TARGETER
ARTHREX, INC.
AR-5400-22
In Commercial Distribution
- 00888867315495 ()
AR-5400-22
- Orthopaedic prosthesis implantation positioning instrument, reusable
SIZE 21 LEG, GLENOID TARGETER
ARTHREX, INC.
AR-5400-21
In Commercial Distribution
- 00888867315488 ()
AR-5400-21
- Orthopaedic prosthesis implantation positioning instrument, reusable
MyPAO Planning report
Medacta International SA
05.07.001SWO
In Commercial Distribution
- 07630971243378 ()
- Orthopaedic/craniofacial implantation planning software
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
- 00810035220515 ()
- 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
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