MRCP+ v1.0

FDA 510(k) K183133 · Perspectum Diagnostics, Ltd.

Substantially Equivalent

510(k) numberK183133

Submission

Device name
MRCP+ v1.0
Applicant
Perspectum Diagnostics, Ltd.
Oxford, GB
Received
November 13, 2018
Decision date
January 9, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was MRCP+ v1.0 cleared by the FDA?

MRCP+ v1.0 (K183133) received a 510(k) decision of Substantially Equivalent on January 9, 2019, 57 days after the submission was received.

What is the product code of K183133?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.