510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092537Substantially Equivalent

Digital X-Ray Sensor, Model E9539,e9505,e9502, E9540

Toshiba America Electronic Components, Inc., Buffalo Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092537 is the FDA 510(k) clearance record for DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540, a class II device, cleared for Toshiba America Electronic Components, Inc. on under FDA product code MUH (System, X-Ray, Extraoral Source, Digital). FDA records list one 510(k) clearance for Toshiba America Electronic Components, Inc. As of , FDA records show no recalls naming K092537.

Clearance record

Decision date
Received
(8 days to decision)
Product code
MUH System, X-Ray, Extraoral Source, Digital
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Toshiba America Electronic Components, Inc. 2150 E. Lake Cook Rd.,, Buffalo Grove IL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MUH

Trailing 12 months
3 clearances under product code MUH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260