510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844549Substantially Equivalent

Head-Spine Stabilizer Hss-1

Imaging Accessories, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844549 is the FDA 510(k) clearance record for HEAD-SPINE STABILIZER HSS-1, a class I device, cleared for Imaging Accessories, Inc. on under FDA product code IWY (Holder, Head, Radiographic). FDA records list 2 510(k) clearances for Imaging Accessories, Inc., from to . As of , FDA records show no recalls naming K844549.

Clearance record

Decision date
Received
(100 days to decision)
Product code
IWY Holder, Head, Radiographic
Regulation
21 CFR 892.1920
Device class
Class I
Review panel
Radiology
Applicant
Imaging Accessories, Inc. 632 17th Ave., Salt Lake City UT
Third party review
No

Clearances, product code IWY

Trailing 12 months

FDA records hold no clearances under product code IWY in the trailing twelve months.

FDA records show no clearances under product code IWY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260