K254131
- 510(k) number
- K254131
- Device name
- BAC
- Applicant
- DeepHealth, Inc. MA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-05-21
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254131.pdf
Official FDA record: K254131
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.