510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K971016Substantially Equivalent

Mrp-7000/Airis Qd C-Spine Coil (P/n Mr-Qcsc-42,Mr-Qcsc-52)

FUJIFILM Healthcare Americas Corporation, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971016 is the FDA 510(k) clearance record for MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52), a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code MOS (Coil, Magnetic Resonance, Specialty). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K971016.

Clearance record

Decision date
Received
(78 days to decision)
Product code
MOS Coil, Magnetic Resonance, Specialty
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 1963 Case Pkwy., Twinsburg OH
510(k) summary
Summary
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