K233568

Ceevra Reveal 3+

510(k) number
K233568
Device name
Ceevra Reveal 3+
Applicant
Ceevra, Inc. CA · US
Product code
QIH — Automated Radiological Image Processing Software
Decision date
2023-12-05
Date received
2023-11-06
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K233568.pdf

Official FDA record: K233568
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.