510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222655Substantially Equivalent

OtoSight Middle Ear Scope

Photonicare Inc, Champaign IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222655 is the FDA 510(k) clearance record for OtoSight Middle Ear Scope, a class II device, cleared for Photonicare, Inc. on under FDA product code QJG (Device System, Imaging, Tympanic Membrane And Middle Ear). FDA's definition for product code QJG reads: "Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space". FDA records list 2 510(k) clearances for Photonicare, Inc., from to . As of , FDA records show no recalls naming K222655.

Clearance record

Decision date
Received
(24 days to decision)
Product code
QJG Device System, Imaging, Tympanic Membrane And Middle Ear
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Photonicare, Inc. 1902 Fox Dr., Champaign IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJG

Trailing 12 months

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

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