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

Cranial Measurement Software

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

QQO is the FDA product code for Cranial Measurement Software, a class I device type, regulated under 21 CFR 878.4800. FDA's definition for this code reads: "Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QQO
Device name
Cranial Measurement Software
FDA definition
Cranial measurement software is intended to be used to calculate and display physical measurements of the head for interpretation by a qualified user in conjunction with other clinical methods.
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QQO

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

Applicants with the most clearances

Product code QQO
Applicants holding the most 510(k) clearances under product code QQO
ApplicantClearances
Pediametrix Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code