510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K112112Substantially Equivalent

Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems

Sentinel Medical, Inc., Toronto, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112112 is the FDA 510(k) clearance record for SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS, a class II device, cleared for Sentinel Medical, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list one 510(k) clearance for Sentinel Medical, Inc. As of , FDA records show no recalls naming K112112.

Clearance record

Decision date
Received
(31 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Sentinel Medical, Inc. 555 Richmond St. W., Toronto, CA
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 October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20261
March 20261
April 20263
May 20260
June 20260
July 20262
August 20260
September 20260
October 20261