510(k) K233662

Radiography 7300 C by Philips Medical Systems Dmc GmbH — Product Code KPR

K233662 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "Radiography 7300 C". The FDA issued a decision of Substantially Equivalent on June 13, 2024. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2024
Date Received
November 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type