← FDA Medical Device Classifications

Source, Calibration, Sealed, Nuclear

IXD · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.1400

Classification

FDA Product Code

IXD

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 892.1400

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

2

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

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