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)

MRCP+ version 2 (MRCP+ v2)

K-Number: K233930 · 2024-03-13

ApplicantPerspectum
Decision Date2024-03-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRCP+ version 2 (MRCP+ v2) is a medical device manufactured by Perspectum. It received FDA 510(k) clearance on 2024-03-13 under approval number K233930. 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 MRCP+ version 2 (MRCP+ v2)?

MRCP+ version 2 (MRCP+ v2) is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Perspectum. The 510(k) number is K233930.

When was MRCP+ version 2 (MRCP+ v2) approved by the FDA?

MRCP+ version 2 (MRCP+ v2) received FDA 510(k) clearance on 2024-03-13, under approval number K233930.

What company makes MRCP+ version 2 (MRCP+ v2)?

MRCP+ version 2 (MRCP+ v2) is manufactured by Perspectum.

What is the FDA product code for MRCP+ version 2 (MRCP+ v2)?

The FDA product code for MRCP+ version 2 (MRCP+ v2) is LLZ.

Other Devices by Perspectum

K213960LiverMultiScan v5 (LMSv5) K230294CoverScan (CoverScan v1.1)

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑