FDA.reportPublic FDA data

Rapid

Primary DI
B761R610
Brand
Rapid
Company
Ischemaview, Inc.
Model
6.1.0
Device description
Rapid System Update
Published
2024-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QASRadiological Computer-Assisted Triage And Notification Software
QFMRadiological Computer-Assisted Prioritization Software For Lesions
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology2
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology2
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193087000
K200760000
K200941000
K213165000
K220499000
K221248000
K221456000
K222884000
K223396000
K230074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193087000Rapid ICHIschemaview Incorporated2020-03-31QAS
K200760000Rapid ASPECTSIschemaview, Inc.2020-06-26POK
K200941000Rapid LVOIschemaview, Inc.2020-07-09QAS
K213165000RapidIschemaview, Inc.2022-02-08LLZ
K220499000Rapid PE Triage and Notification (PETN)Ischemaview, Inc.2022-05-17QAS
K221248000Rapid LVOIschemaview, Inc.2022-05-31QAS
K221456000Rapid ICHIschemaview, Inc.2022-09-12QAS
K222884000Rapid NCCT StrokeIschemaview, Inc.2023-03-02QAS
K223396000Rapid RV/LVIschemaview, Inc.2023-02-01QIH
K230074000Rapid Aneurysm Triage and NotificationIschemaview, Inc.2023-07-27QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B761R610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
303-704-3374rosa@ischemaview.com

Regulatory Flags#

DUNS number
079477740
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B761R51011Rapid5.1012024-02-13
B761R51020Rapid5.1022024-02-13
B761R5711Rapid5.7.1Rapid2024-02-13
B761R5721Rapid5.7.2Rapid2024-02-13
B761R60Rapid6.x2025-05-07
B761R5701Rapid5.7Rapid2023-06-29
B761R591Rapid5.92023-06-29
B7615511Rapid5.5.12022-11-10
B7671R511Rapid5.1.1Rapid2022-05-25
B7671R512Rapid5.1.2Rapid2022-05-25
B7671R520Rapid5.2.0Rapid2022-05-25
B7671R521Rapid5.2.2Rapid2022-05-25
B7671R522Rapid5.2.2Rapid2022-05-25
B761RAPID510Rapid5.1Rapid 5.12020-07-06
B7671R5030Rapid5.0.32020-05-06
B761RAPID49101RAPID4.9.1Rapid2020-04-07
B761RAPID500RAPID5.0Rapid2020-04-07
B761RAPID5010RAPID5.0.12020-04-07
B761RAPID5020RAPID5.0.22020-04-07
B761RAPID50210RAPID5.0.2.1Rapid2020-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.LLZ2026-10-19
05745000308385Cercare Medical NeurosuiteCercare Medical A/SLLZ2026-10-17
05745000308392Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-10-17
05745000308408Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SLLZ2026-10-16
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SQIH2026-10-16
75401622502301Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-16
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
19356870000069PHA4DMEDICAL LIMITEDQIH2026-10-13
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
00198953083246VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
08809887550170EdgeFlow UH10CEdgeCare Inc.QIH2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25