FDA.reportPublic FDA data

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad

Primary DI
00817100020209
Brand
Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad
Company
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Model
OPAL 02-04-04-000
Device description
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
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
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817100020209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817100020209008171000202098171000202090817100020209

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstationA freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080269345
Device count
1
Lot or batch
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
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
008171000203084143C CsI Compact Digital Flat Panel DetectorPAN2612016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
04056869297309MOBILETT ImpactSiemens Healthcare GmbHKPR2025-11-20
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
04540217071319RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
04540217071326RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
04056869279985MULTIX ImpactSiemens Shanghai Medical Equipment Ltd.KPR2021-04-20
04056869262147MULTIX Impact CSiemens Shanghai Medical Equipment Ltd.KPR2021-03-22
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
00810030350002uDRUIH TECHNOLOGIES LLCKPR2020-04-29
08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20
08800011121242FDR ClinicaDRGEM CorporationKPR2019-11-20