Concentriq AP-Dx— 510(k) K261380
Substantially EquivalentProscia, Inc.
FDA 510(k) clearance K261380 for Concentriq AP-Dx, Substantially Equivalent on 2026-08-05. Applicant: Proscia, Inc.. Device class: 2.
Summary
Proscia's Concentriq AP-Dx is filed under product code QKQ, digital pathology image viewing and management software. The record doesn't expand AP-Dx.
Class II, 21 CFR 864.3700. Pathology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Proscia filed from Philadelphia, Pennsylvania. The decision came 100 calendar days after receipt (April 27 to August 5, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Proscia, Inc.
- Product code
- Product code QKQ
- Device class
- Class 2
- Regulation
- 21 CFR 864.3700
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Philadelphia, PA, US
Recent devices under product code QKQ
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