510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915667Substantially Equivalent

Model H170 Pediatric Chest X-Ray Unit

H.L. Lyons Co., Louisville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915667 is the FDA 510(k) clearance record for MODEL H170 PEDIATRIC CHEST X-RAY UNIT, a class I device, cleared for H.L. Lyons Co. on under FDA product code IXY (Holder, Radiographic Cassette, Wall-Mounted). FDA records list one 510(k) clearance for H.L. Lyons Co. As of , FDA records show no recalls naming K915667.

Clearance record

Decision date
Received
(44 days to decision)
Product code
IXY Holder, Radiographic Cassette, Wall-Mounted
Regulation
21 CFR 892.1880
Device class
Class I
Review panel
Radiology
Applicant
H.L. Lyons Co. 11401 Electron Dr., Louisville KY
510(k) summary
Statement
Third party review
No

Clearances, product code IXY

Trailing 12 months

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

FDA records show no clearances under product code IXY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXY, 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