510(k) clearance
BlineSlide
- 510(k) number
- K261679
- Applicant
- Deep Breathe, Inc.
- Decision date
- Oct 23, 2026
- Date received
- May 21, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- POK
- Device type
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Device class
- Class II
- Regulation
- 21 CFR 892.2060
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- London, CA