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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K261380

510(k) cleared

Concentriq AP-Dx

Proscia, Inc. · Aug 5, 2026 · K261380

FDA cleared the Concentriq AP-Dx from Proscia, Inc. on Aug 5, 2026 under K261380, a traditional 510(k). The device falls under product code QKQ, Digital Pathology Image Viewing And Management Software, regulated at 21 CFR 864.3700 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Apr 27, 2026. The decision came 100 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Proscia, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261380?

K261380 is the FDA 510(k) for Concentriq AP-Dx, submitted by Proscia, Inc.. FDA's decision date was Aug 5, 2026, under product code QKQ (Digital Pathology Image Viewing And Management Software).

Who makes the Concentriq AP-Dx?

Proscia, Inc., based in Philadelphia, PA, is the applicant of record for K261380.

How long did the K261380 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Aug 5, 2026, 100 days later.

← All decisions in August 2026