CoverScan (CoverScan v1.1)
FDA 510(k) K230294 · Perspectum
510(k) numberK230294
Submission
- Device name
- CoverScan (CoverScan v1.1)
- Applicant
- Perspectum
Oxford, GB - Received
- February 2, 2023
- Decision date
- March 3, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K202170 | LiverMultiScanLNH · Traditional | 10/02/2020SE |
Questions and answers
When was CoverScan (CoverScan v1.1) cleared by the FDA?
CoverScan (CoverScan v1.1) (K230294) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 29 days after the submission was received.
What is the product code of K230294?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.