510(k) clearance
ChestView US (1.1)
- 510(k) number
- K252486
- Applicant
- Gleamer
- Decision date
- Sep 9, 2026
- Date received
- Aug 7, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MYN
- Device type
- Analyzer, Medical Image
- Device class
- Class II
- Regulation
- 21 CFR 892.2070
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Paris, FR