FDA.reportPublic FDA data

Portable X-Ray System

Primary DI
00817100020353
Brand
Portable X-Ray System
Company
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Model
XR301
Device description
Portable X-Ray System-R
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K030494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030494000SR-130Source-Ray, Inc.2003-05-20IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817100020353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817100020353008171000203538171000203530817100020353

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

Contacts#

Phone, Email table
PhoneEmail
1-800-366-5343HTICSupport@konicaminolta.com

Regulatory Flags#

DUNS number
080269345
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817100021268KDR DDR Primary U Arm Primary2025-07-30
00817100020278KDR Floor Mount+ SystemKDR FMT+2026-01-08
00817100021282KDR Floor Mount SystemKDR FMT2026-01-08
00817100020360CR ReaderCR302016-09-24
00817100020391CR ReaderCRII602016-09-24
0081710002046910X12 Cassette for CR ReaderCASCR24302016-10-05
0081710002047614X17 Cassette for CR ReaderCASCR35432016-10-05
00817100020124Portable X-Ray SystemXR3102016-09-30
0081710002025414X17 Wireless GOS Flat Panel DetectorPAN2002016-09-24
00817100020315RF 14X17 Sensor PanelPAN2902016-09-24
00817100020483RF 11X14 Sensor PanelPAN2912016-10-06
00817100020513RF 11X14 Sensor PanelPAN2922017-04-30
00817100020193Konica Minolta SW (PACS) ExaEXA 01-04-0002016-09-24
00817100020209Konica Minolta SW (PACS) Opal Rad, 20/20 Opal RadOPAL 02-04-04-0002016-09-24
0081710002021617X17 CsI Fixed Flat Panel DetectorPAN2202016-09-24
0081710002022317X17 GOS Fixed Flat Panel DetectorPAN2212016-09-24
0081710002023014X17 Portable GOS Flat Panel DetectorPAN2402016-09-24
0081710002024714X17 Portable GOS Flat Panel Detector without USBPAN2412016-09-24
008171000202614343 CsI Digital Flat Panel DetectorPAN2602016-09-24
008171000202853543EZ CsI Digital Wireless Flat Panel Detector PAN2802016-10-05

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