ProstatID— 510(k) K212783
Substantially EquivalentScanmed, LLC
FDA 510(k) clearance K212783 for ProstatID, Substantially Equivalent on 2022-07-08. Applicant: Scanmed, LLC. Device class: 2.
Clearance details
- Applicant
- Scanmed, LLC
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Omaha, NE, US
Recent devices under product code QDQ
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