Koios DS for Breast— 510(k) K190442
Substantially EquivalentKoios Medical, Inc.
FDA 510(k) clearance K190442 for Koios DS for Breast, Substantially Equivalent on 2019-07-03. Applicant: Koios Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Koios Medical, Inc.
- Product code
- Code POK
- Device class
- Class 2
- Regulation
- 21 CFR 892.2060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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