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

Device System, Imaging, Tympanic Membrane And Middle Ear

21 CFR 892.1560 / Radiology
FDA source (opens on fda.gov)

QJG is the FDA product code for Device System, Imaging, Tympanic Membrane And Middle Ear, a class II device type, regulated under 21 CFR 892.1560. FDA's definition for this code reads: "Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QJG
Device name
Device System, Imaging, Tympanic Membrane And Middle Ear
FDA definition
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QJG

By decision year
2 clearances under product code QJG with a decision year between 2019 and 2022, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QJG by decision year
YearClearances
20191
20221

Applicants with the most clearances

Product code QJG
Applicants holding the most 510(k) clearances under product code QJG
ApplicantClearances
Photonicare Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code