K242338
- 510(k) number
- K242338
- Device name
- Cleerly LABS (v2.0)
- Applicant
- Cleerly, Inc. CO · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-03-07
- Date received
- 2024-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K242338.pdf
Official FDA record: K242338
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.