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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
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPR55
In Commercial Distribution
- 08809458319960 ()
- General surgical procedure kit, non-medicated, single-use
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPN50
In Commercial Distribution
- 08809458319953 ()
- General surgical procedure kit, non-medicated, single-use
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPI62
In Commercial Distribution
- 08806343918567 ()
- General surgical procedure kit, non-medicated, single-use
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPW62
In Commercial Distribution
- 08806343918550 ()
- General surgical procedure kit, non-medicated, single-use
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPR62
In Commercial Distribution
- 08806343918543 ()
- General surgical procedure kit, non-medicated, single-use
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPR52
In Commercial Distribution
- 08806343918536 ()
- General surgical procedure kit, non-medicated, single-use
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Shinhung MST Co., Ltd.
SBPN42
In Commercial Distribution
- 08806343918529 ()
- General surgical procedure kit, non-medicated, single-use