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
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21
00198953042731LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042755LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042762LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042779LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953042793LOGIQGE Ultrasound Korea Ltd.QIH2025-12-05
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10