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 / November 2025 / K251792

510(k) cleared

Stereotaxis GenesisX RMN with Navigant Workstation (NWS)

Stereotaxis, Inc. · Nov 6, 2025 · K251792

FDA cleared the Stereotaxis GenesisX RMN with Navigant Workstation (NWS) from Stereotaxis, Inc. on Nov 6, 2025 under K251792, a traditional 510(k). The device falls under product code DXX, System, Catheter Control, Steerable, regulated at 21 CFR 870.1290 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 11, 2025. The decision came 148 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stereotaxis, Inc. has 2 other decisions in the tracker over the last 12 months: K253473 (Synchrony), P240014 (MAGiC Ablation Catheter).

Questions & Answers

What did FDA clear under K251792?

K251792 is the FDA 510(k) for Stereotaxis GenesisX RMN with Navigant Workstation (NWS), submitted by Stereotaxis, Inc.. FDA's decision date was Nov 6, 2025, under product code DXX (System, Catheter Control, Steerable).

Who makes the Stereotaxis GenesisX RMN with Navigant Workstation (NWS)?

Stereotaxis, Inc., based in Saint Louis, MO, is the applicant of record for K251792.

How long did the K251792 review take?

FDA received the submission on Jun 11, 2025 and issued its decision on Nov 6, 2025, 148 days later.

← All decisions in November 2025

Sources