K234030

Clear Guide SCENERGY

510(k) number
K234030
Device name
Clear Guide SCENERGY
Applicant
Clear Guide Medical MD · US
Product code
JAK — System, X-Ray, Tomography, Computed
Decision date
2024-01-17
Date received
2023-12-20
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain

Also available from FDA: K234030.pdf

Official FDA record: K234030
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.