MRCP+ version 2 (MRCP+ v2)
FDA 510(k) K233930 · Perspectum
510(k) numberK233930
Submission
- Device name
- MRCP+ version 2 (MRCP+ v2)
- Applicant
- Perspectum
Oxford, GB - Received
- December 14, 2023
- Decision date
- March 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
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| K213960 | LiverMultiScan v5 (LMSv5)LNH · Traditional | 09/06/2022SE |
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| K203280 | Hepatica v1 (Hepatica v1.0.0)LNH · Traditional | 01/12/2021SE |
| K202170 | LiverMultiScanLNH · Traditional | 10/02/2020SE |
Questions and answers
When was MRCP+ version 2 (MRCP+ v2) cleared by the FDA?
MRCP+ version 2 (MRCP+ v2) (K233930) received a 510(k) decision of Substantially Equivalent on March 13, 2024, 90 days after the submission was received.
What is the product code of K233930?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.