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

Image Management Software For Planning Of Otologic And Neurotologic Procedures

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

QQE is the FDA product code for Image Management Software For Planning Of Otologic And Neurotologic Procedures, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QQE
Device name
Image Management Software For Planning Of Otologic And Neurotologic Procedures
FDA definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
Regulation
21 CFR 892.2050
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
3
Ingested recalls
0

Clearances, product code QQE

By decision year
3 clearances under product code QQE with a decision year between 2021 and 2025, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QQE by decision year
YearClearances
20211
20221
20251

Applicants with the most clearances

Product code QQE
Applicants holding the most 510(k) clearances under product code QQE
ApplicantClearances
Cascination3

Companies listing this code with FDA

Companies whose registered establishments list this code