← FDA Medical Device Classifications

Monitor, Patient Position, Light-Beam

IWE · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.5780

Classification

FDA Product Code

IWE

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 892.5780

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

28

Registered establishments

20

Source

Authoritative

FDA Device Classification database

Machine

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