← FDA Medical Device Classifications

Camera, Positron

IZC · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.1110

Classification

FDA Product Code
IZC
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 892.1110
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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