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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 / December 2025 / K253532

510(k) cleared

TruSPECT Processing Station

Spectrum Dynamics Medical, Ltd. · Dec 30, 2025 · K253532

FDA cleared the TruSPECT Processing Station from Spectrum Dynamics Medical, Ltd. on Dec 30, 2025 under K253532, a special 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 13, 2025. The decision came 47 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: K254001 (VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)).

Questions & Answers

What did FDA clear under K253532?

K253532 is the FDA 510(k) for TruSPECT Processing Station, submitted by Spectrum Dynamics Medical, Ltd.. FDA's decision date was Dec 30, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the TruSPECT Processing Station?

Spectrum Dynamics Medical, Ltd., based in Caesarea, is the applicant of record for K253532.

How long did the K253532 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Dec 30, 2025, 47 days later.

← All decisions in December 2025

Sources