← FDA Medical Device Classifications

Phantom, Anthropomorphic, Radiographic

IXG · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.1950

Classification

FDA Product Code
IXG
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 892.1950
Review panel
RA
Medical specialty
Radiology
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
4
Registered establishments
22

Source

Authoritative
FDA Device Classification database
Machine
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