Last synced on 16 May 2025 at 11:05 pm

Diagnostic X-Ray Equipment (Noncertified)

Page Type
Product Code
Definition
Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code RBR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Diagnostic X-Ray Equipment (Noncertified)

Page Type
Product Code
Definition
Diagnostic x-ray equipment or components manufactured before the dates specified in the applicability section in 21 cfr 1020.30(a).
Device Classification
N
GMP Exempt?
Yes
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code RBR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.