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FDA 510(k)

Rapid ASPECTS (v3)

K-Number: K232156 · 2024-01-19

ApplicantIschemaview, Inc.
Decision Date2024-01-19
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid ASPECTS (v3) is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2024-01-19 under approval number K232156. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid ASPECTS (v3)?

Rapid ASPECTS (v3) is a medical device that received FDA 510(k) clearance on 2024-01-19. It is manufactured by Ischemaview, Inc.. The 510(k) number is K232156.

When was Rapid ASPECTS (v3) approved by the FDA?

Rapid ASPECTS (v3) received FDA 510(k) clearance on 2024-01-19, under approval number K232156.

What company makes Rapid ASPECTS (v3)?

Rapid ASPECTS (v3) is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid ASPECTS (v3)?

The FDA product code for Rapid ASPECTS (v3) is POK.

Other Devices by Ischemaview, Inc.

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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.

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