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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 / November 2025 / K250525

510(k) cleared

Second Opinion® Panoramic

Pearl, Inc. · Nov 14, 2025 · K250525

FDA cleared the Second Opinion® Panoramic from Pearl, Inc. on Nov 14, 2025 under K250525, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Feb 21, 2025. The decision came 266 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 Pearl, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250525?

K250525 is the FDA 510(k) for Second Opinion® Panoramic, submitted by Pearl, Inc.. FDA's decision date was Nov 14, 2025, under product code MYN (Analyzer, Medical Image).

Who makes the Second Opinion® Panoramic?

Pearl, Inc., based in Beverly Hills, CA, is the applicant of record for K250525.

How long did the K250525 review take?

FDA received the submission on Feb 21, 2025 and issued its decision on Nov 14, 2025, 266 days later.

← All decisions in November 2025