510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053017Substantially Equivalent

Models Hrs-63-8 and Hrs-127-8 Shoulder Array Coils

Invivo Corporation, Pewaukee WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K053017 is the FDA 510(k) clearance record for MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS, a class II device, cleared for Invivo Corporation on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 50 510(k) clearances for Invivo Corporation, from to . As of , FDA records show one recall naming K053017.

Clearance record

Decision date
Received
(21 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Invivo Corporation N27 W23676 Paul Rd., Pewaukee WI
510(k) summary
Statement
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