510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K063342Substantially Equivalent

Medrad Ecoil Imaging System for Philips

Medrad, Inc., Indianola PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063342 is the FDA 510(k) clearance record for MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS, a class II device, cleared for Medrad, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K063342.

Clearance record

Decision date
Received
(24 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Medrad, Inc. One Medrad Dr., Indianola PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOS

Trailing 12 months
10 clearances under product code MOS in the twelve months to November 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOS, trailing twelve months
MonthClearances
December 20250
January 20262
February 20261
March 20261
April 20263
May 20260
June 20260
July 20262
August 20260
September 20260
October 20261
November 20260