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RadmediX, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091346553009134655RadmediX, LLC1Y2026-01-012510 Lance Dr. Dayton OH US 45409

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1297241857066566K231995AcuityUDRKPR2023-10-25
1297241974134125K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4MQB2023-07-12
1297241864502552K223010Portable X-ray SystemEHD2023-01-17
1297241444093094K210919AcuityDReMQB2021-04-30
1297241464456866K200726AcuityPDRIZL2020-04-13
1297241162109441K193360Acuity SDR Standard, Acuity SDR Plus, Acuity FDR StandardKPR2020-01-02
1297241187376158K193017EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WPMQB2019-11-22
1297241139453995K171137EVS 2430W, EVS 2430GWMQB2017-05-15
1297242031539116K170930RSM 2430CMUE2017-04-27
1297241052935648K162670RSM 1824C with RConsole1MUE2017-02-23
1297241705988106K162555EVS 4343, EVS 4343GMQB2016-12-21
1297241779662301K162552EVS 3643, EVS 3643GMQB2016-12-02
1297241821579257K152172Econsole1LLZ2015-12-14
1297241560265620K102849ACCULMAINGLLZ2010-11-23
1297241180359064K091364DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4LLZ2009-12-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB62023-07-12
LLZ42015-12-14
KPR32023-10-25
MUE22017-04-27
EHD12023-01-17
IZL12020-04-13

PMN#

GUDID#

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.

RADMEDIX, LLC

2023-12-18

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.

RADMEDIX, LLC

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.

RADMEDIX, LLC

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.

RADMEDIX, LLC

2023-07-20

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