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FDA 510(k)

CoverScan (CoverScan v1.1)

K-Number: K230294 · 2023-03-03

ApplicantPerspectum
Decision Date2023-03-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CoverScan (CoverScan v1.1) is a medical device manufactured by Perspectum. It received FDA 510(k) clearance on 2023-03-03 under approval number K230294. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoverScan (CoverScan v1.1)?

CoverScan (CoverScan v1.1) is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Perspectum. The 510(k) number is K230294.

When was CoverScan (CoverScan v1.1) approved by the FDA?

CoverScan (CoverScan v1.1) received FDA 510(k) clearance on 2023-03-03, under approval number K230294.

What company makes CoverScan (CoverScan v1.1)?

CoverScan (CoverScan v1.1) is manufactured by Perspectum.

What is the FDA product code for CoverScan (CoverScan v1.1)?

The FDA product code for CoverScan (CoverScan v1.1) is LLZ.

Other Devices by Perspectum

K213960LiverMultiScan v5 (LMSv5) K233930MRCP+ version 2 (MRCP+ v2)

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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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