K242512

ROCC Console

510(k) number
K242512
Device name
ROCC Console
Applicant
Philips Medical Systems Nederland B.V. NL
Product code
LLZ — System, Image Processing, Radiological
Decision date
2024-10-24
Date received
2024-08-23
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
510(k) Summary (official FDA PDF): K242512.pdf
Official FDA record: K242512
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.