510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K183186Substantially Equivalent

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24

Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183186 is the FDA 510(k) clearance record for Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24, a class II device, cleared for Shanghai United Imaging Healthcare Co., Ltd. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 84 510(k) clearances for Shanghai United Imaging Healthcare Co., Ltd., from to . As of , FDA records show no recalls naming K183186.

Clearance record

Decision date
Received
(81 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Shanghai United Imaging Healthcare Co., Ltd. 2258 Chengbei Rd., Jiading Industrial District, Shanghai, CN
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