WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / September 2025 / K251682

510(k) cleared

MuscleView 2.0

Springbok, Inc. (Dba Springbok Analytics) · Sep 9, 2025 · K251682

FDA cleared the MuscleView 2.0 from Springbok, Inc. (Dba Springbok Analytics) on Sep 9, 2025 under K251682, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 30, 2025. The decision came 102 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 Springbok, Inc. (Dba Springbok Analytics) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251682?

K251682 is the FDA 510(k) for MuscleView 2.0, submitted by Springbok, Inc. (Dba Springbok Analytics). FDA's decision date was Sep 9, 2025, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the MuscleView 2.0?

Springbok, Inc. (Dba Springbok Analytics), based in Charlottesville, VA, is the applicant of record for K251682.

How long did the K251682 review take?

FDA received the submission on May 30, 2025 and issued its decision on Sep 9, 2025, 102 days later.

← All decisions in September 2025