← FDA Medical Device Classifications

Camera, Multi Format, Radiological

LMC · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2040

Classification

FDA Product Code
LMC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.2040
Review panel
RA
Medical specialty
Radiology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
121
Registered establishments
16

Source

Authoritative
FDA Device Classification database
Machine
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