FDA.reportPublic FDA data

Rapid

Primary DI
B761R5721
Brand
Rapid
Company
Ischemaview, Inc.
Model
5.7.2
Catalog number
Rapid
Device description
Rapid System Update
Published
2024-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182130000
K193087000
K200760000
K213165000
K220499000
K221248000
K221456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182130000iSchemaView RAPIDIschemaview, Inc.2018-12-27LLZ
K193087000Rapid ICHIschemaview Incorporated2020-03-31QAS
K200760000Rapid ASPECTSIschemaview, Inc.2020-06-26POK
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B761R5721PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Contacts#

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

Regulatory Flags#

DUNS number
079477740
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B761R60Rapid 6.x2025-05-07
B761RAPID48302RAPID4.8.3RAPID2019-06-12
B761R51011Rapid5.1012024-02-13
B761R51020Rapid5.1022024-02-13
B761R5711Rapid5.7.1Rapid2024-02-13
B761R610Rapid6.1.02024-02-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200589JLK-ICHJLK, Inc.QAS2026-03-25
08800066200596JLK-LVOJLK, Inc.QAS2026-03-25
08800066200602JLK-SDHJLK, Inc.QAS2026-03-25
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28