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

Wound Autofluorescence Imaging Device

21 CFR 878.4165 / General, Plastic Surgery
FDA source (opens on fda.gov)

QCR is the FDA product code for Wound Autofluorescence Imaging Device, a class I device type, regulated under 21 CFR 878.4165. FDA's definition for this code reads: "A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QCR
Device name
Wound Autofluorescence Imaging Device
FDA definition
A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
Regulation
21 CFR 878.4165
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 QCR

By decision year
1 clearance under product code QCR with a decision year between 2018 and 2018, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QCR by decision year
YearClearances
20181

Applicants with the most clearances

Product code QCR
Applicants holding the most 510(k) clearances under product code QCR
ApplicantClearances
Moleculight Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code