AcuityUDR
Radmedix, LLC
RadmediX, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009134655 | 3009134655 | RadmediX, LLC | 1 | Y | 2026-01-01 | 2510 Lance Dr. Dayton OH US 45409 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 129724 | 1857066566 | K231995 | AcuityUDR | KPR | 2023-10-25 |
| 129724 | 1974134125 | K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | MQB | 2023-07-12 |
| 129724 | 1864502552 | K223010 | Portable X-ray System | EHD | 2023-01-17 |
| 129724 | 1444093094 | K210919 | AcuityDRe | MQB | 2021-04-30 |
| 129724 | 1464456866 | K200726 | AcuityPDR | IZL | 2020-04-13 |
| 129724 | 1162109441 | K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | KPR | 2020-01-02 |
| 129724 | 1187376158 | K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | MQB | 2019-11-22 |
| 129724 | 1139453995 | K171137 | EVS 2430W, EVS 2430GW | MQB | 2017-05-15 |
| 129724 | 2031539116 | K170930 | RSM 2430C | MUE | 2017-04-27 |
| 129724 | 1052935648 | K162670 | RSM 1824C with RConsole1 | MUE | 2017-02-23 |
| 129724 | 1705988106 | K162555 | EVS 4343, EVS 4343G | MQB | 2016-12-21 |
| 129724 | 1779662301 | K162552 | EVS 3643, EVS 3643G | MQB | 2016-12-02 |
| 129724 | 1821579257 | K152172 | Econsole1 | LLZ | 2015-12-14 |
| 129724 | 1560265620 | K102849 | ACCULMAING | LLZ | 2010-11-23 |
| 129724 | 1180359064 | K091364 | DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 | LLZ | 2009-12-11 |
Product Codes Associated With Registrations#
PMN#
AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
Radmedix, LLC
AcuityDRe
Radmedix LLC
Accuvue+
Radmedix LLC
AcuityPDR
Radmedix LLC
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
Radmedix LLC
GUDID#
Radmedix AcuityDRe 1717t - 1
2025-10-28
Acuity DX+ - 1
2025-04-11
Radmedix AcuityUDR - RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 21CFR 892.1680 Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
2023-12-18
Radmedix AccuVue+ - A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
2020-06-09
Radmedix AcuityDR 1717 G4 - 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.
2023-07-20
Radmedix AcuityDR 1417 G4 - 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.
2023-07-20
Radmedix AcuityDR 1013 G4 - 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.
2023-07-20
Radmedix AcuityDRe 1417w - 1
2022-11-02
Radmedix AcuityDRe 1717w - 1
2022-11-02
Radmedix AcuityUDR - 1
2021-11-29
Radmedix AcuityPDR+ - 1
2021-11-29
AcuityDRe - 1
2021-05-24
Radmedix AcuityFDR - 1
2020-09-18
Radmedix AcuityFDR+ - 1
2020-09-18
Radmedix AcuityCDR - 1
2020-09-18
Radmedix AcuitySDR - 1
2020-09-18
Radmedix AcuitySDR+ - 1
2020-09-18
Radmedix AcuityPDR - 1
2020-09-18
AcuityPDR - Standard
2020-06-04
AcuityPDR - Standard
2020-06-04
AcuityPDR - Standard
2020-06-04
AcuityPDR - Standard
2020-06-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04
AcuityPDR - Standard
2020-05-04