FDA.reportPublic FDA data

Rapid

Primary DI
B761R51020
Brand
Rapid
Company
Ischemaview, Inc.
Model
5.102
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
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
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
K220499000
K223396000
K230074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220499000Rapid PE Triage and Notification (PETN)Ischemaview, Inc.2022-05-17QAS
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
B761R51020PrimaryHIBCC0

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
B761R5711Rapid5.7.1Rapid2024-02-13
B761R5721Rapid5.7.2Rapid2024-02-13
B761R610Rapid6.1.02024-02-13
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

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