Cleared Traditional

CoverScan v1

K212565 · Perspectum, Ltd. · Radiology
May 2022
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K212565 is an FDA 510(k) clearance for the CoverScan v1, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Perspectum, Ltd. (Oxford, GB). The FDA issued a Cleared decision on May 19, 2022, 279 days after receiving the submission on August 13, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K212565 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2021
Decision Date May 19, 2022
Days to Decision 279 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050