K233749

Revolution Ascend Sliding

510(k) number
K233749
Device name
Revolution Ascend Sliding
Applicant
Ge Hangwei Medical Systems Co., Ltd. CN
Product code
JAK — System, X-Ray, Tomography, Computed
Decision date
2024-02-22
Date received
2023-11-22
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain

Also available from FDA: K233749.pdf

Official FDA record: K233749
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.