FDA.reportPublic FDA data

Radmedix AcuityPDR

Primary DI
00810035220430
Brand
Radmedix AcuityPDR
Company
RADMEDIX, LLC
Model
1
Published
2020-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200726000AcuityPDRRadmedix, LLC2020-04-13IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810035220430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810035220430008100352204308100352204300810035220430

GMDN Terms#

Term, Definition table
TermDefinition
Portable basic diagnostic x-ray system, digitalAn assembly of devices that comprise a general-purpose portable diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and easily reassembled for use. It consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
005057263
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810035220546Radmedix AcuityDRe 1717t12025-10-28
00810035220539Acuity DX+12025-04-11
00810035220522Radmedix AcuityUDR12023-12-18
00810035220379Radmedix AccuVue+52020-06-09
00810035220492Radmedix AcuityDR 1717 G412023-07-20
00810035220508Radmedix AcuityDR 1417 G412023-07-20
00810035220515Radmedix AcuityDR 1013 G412023-07-20
00810035220478Radmedix AcuityDRe 1417w12022-11-02
00810035220485Radmedix AcuityDRe 1717w12022-11-02
00810035220454Radmedix AcuityUDR12021-11-29
00810035220461Radmedix AcuityPDR+12021-11-29
00810035220447AcuityDRe12021-05-24
00810035220386Radmedix AcuityFDR12020-09-18
00810035220393Radmedix AcuityFDR+12020-09-18
00810035220409Radmedix AcuityCDR12020-09-18
00810035220416Radmedix AcuitySDR12020-09-18
00810035220423Radmedix AcuitySDR+12020-09-18
00810035220331AcuityPDRStandard2020-06-04
00810035220348AcuityPDRStandard2020-06-04
00810035220355AcuityPDRStandard2020-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21