510(k) K233678

Radiography 7000 M by Philips Medical Systems Dmc GmbH — Product Code IZL

K233678 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Dmc GmbH for the device "Radiography 7000 M". The FDA issued a decision of Substantially Equivalent on February 14, 2024. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Philips Medical Systems Dmc GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2024
Date Received
November 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type