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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 / March 2026 / K253520

510(k) cleared

Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, LLC · Mar 20, 2026 · K253520

FDA cleared the Photonova Spectra, Photonova Spectra Select from Ge Medical Systems, LLC on Mar 20, 2026 under K253520, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 12, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ge Medical Systems, LLC has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K253520?

K253520 is the FDA 510(k) for Photonova Spectra, Photonova Spectra Select, submitted by Ge Medical Systems, LLC. FDA's decision date was Mar 20, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Photonova Spectra, Photonova Spectra Select?

Ge Medical Systems, LLC, based in Waukesha, WI, is the applicant of record for K253520.

How long did the K253520 review take?

FDA received the submission on Nov 12, 2025 and issued its decision on Mar 20, 2026, 128 days later.

← All decisions in March 2026