Radmedix AcuityDR 1013 G4
RADMEDIX, LLC · Model 1 · UDI-DI 00810035220515
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-01 | Philips North America Llc | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. |
| 2025-10-01 | Philips Medical Systems DMC GmbH | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/ph |
| 2023-05-19 | Philips North America Llc | There is a software login in issue that may prevent the user from logging in. |
| 2021-09-22 | Philips Healthcare | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation W |
| 2021-03-11 | LIEBEL-FLARSHEIM COMPANY LLC | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual valu |
| 2021-02-05 | Canon Medical System, USA, INC. | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. |
| 2020-12-08 | Canon Medical System, USA, INC. | System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. |
| 2020-04-06 | Siemens Medical Solutions USA, Inc | It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will |
| 2020-03-03 | Canon Medical System, USA, INC. | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. |
| 2020-01-07 | Palodex Group Oy | Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and |
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