FDA.reportPublic FDA data

Konica Minolta Software Opal Acquire

Primary DI
00817100020421
Brand
Konica Minolta Software Opal Acquire
Company
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
Model
OPALACQ-02-03-04-000
Device description
Software, Opal Acquire Image Acquisition Software
Published
2016-09-27
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817100020421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817100020421008171000204218171000204210817100020421

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system 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
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
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00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03