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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 / January 2026 / K254001

510(k) cleared

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Spectrum Dynamics Medical, Ltd. · Jan 13, 2026 · K254001

FDA cleared the VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) from Spectrum Dynamics Medical, Ltd. on Jan 13, 2026 under K254001, a special 510(k). The device falls under product code KPS, System, Tomography, Computed, Emission, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 15, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Spectrum Dynamics Medical, Ltd. has one other decision in the tracker over the last 12 months: K253532 (TruSPECT Processing Station).

Questions & Answers

What did FDA clear under K254001?

K254001 is the FDA 510(k) for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464), submitted by Spectrum Dynamics Medical, Ltd.. FDA's decision date was Jan 13, 2026, under product code KPS (System, Tomography, Computed, Emission).

Who makes the VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)?

Spectrum Dynamics Medical, Ltd., based in Caesarea, is the applicant of record for K254001.

How long did the K254001 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jan 13, 2026, 29 days later.

← All decisions in January 2026

Sources