← FDA Medical Device Classifications

Generator, High-Voltage, X-Ray, Diagnostic

IZO · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.1700

Classification

FDA Product Code

IZO

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 892.1700

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

163

Registered establishments

41

Source

Authoritative

FDA Device Classification database

Machine

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