510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100113Substantially Equivalent

Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for Ge 3T MRI System, Model 4000451-51

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

K100113 is the FDA 510(k) clearance record for VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51, a class II device, cleared for Sentinelle Medical, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 5 510(k) clearances for Sentinelle Medical, Inc., from to . As of , FDA records show one recall naming K100113.

Clearance record

Decision date
Received
(98 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Sentinelle Medical, Inc. 555 Richmond St. W, Toronto, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOS

Trailing 12 months
9 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 20260