Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rapid ICH

K-Number: K221456 · 2022-09-12

ApplicantIschemaview, Inc.
Decision Date2022-09-12
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid ICH is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2022-09-12 under approval number K221456. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid ICH?

Rapid ICH is a medical device that received FDA 510(k) clearance on 2022-09-12. It is manufactured by Ischemaview, Inc.. The 510(k) number is K221456.

When was Rapid ICH approved by the FDA?

Rapid ICH received FDA 510(k) clearance on 2022-09-12, under approval number K221456.

What company makes Rapid ICH?

Rapid ICH is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid ICH?

The FDA product code for Rapid ICH is QAS.

Other Devices by Ischemaview, Inc.

K182130iSchemaView RAPID K172477iSchemaView RAPID K200941Rapid LVO K200760Rapid ASPECTS K221248Rapid LVO K220499Rapid PE Triage and Notification (PETN)

View all 20 devices →

Related Devices (Code: QAS)

K182177AccipiolxMaxq-Al , Ltd. K180647BriefCaseAidoc Medical , Ltd. DEN170073ContaCTViz.Al, Inc. K192383BriefCaseAidoc Medical , Ltd. K182875DeepCTDeep01 Limited K190424HealthICHZebra Medical Vision, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑