← FDA Medical Device Classifications

Diagnostic X-Ray Equipment (Noncertified)

RBR · Not classified · Unknown

Classification

FDA Product Code
RBR
Device class
Not classified
Regulation
Review panel
Medical specialty
Unknown
Submission type
GMP exempt
Y
Life sustaining
Implant
Third-party review

Definition

Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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