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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 / January 2026 / K253023

510(k) cleared

BIOGRAPH One

Siemens Healthineers AG · Jan 15, 2026 · K253023

FDA cleared the BIOGRAPH One from Siemens Healthineers AG on Jan 15, 2026 under K253023, a traditional 510(k). The device falls under product code OUO, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Healthineers AG has 4 other decisions in the tracker over the last 12 months: K260852 (MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure), K253690 (LungMaps), K253495 (syngo.MR Applications (VB80)), K251059 (Syngo Carbon Clinicals (VA41)).

Questions & Answers

What did FDA clear under K253023?

K253023 is the FDA 510(k) for BIOGRAPH One, submitted by Siemens Healthineers AG. FDA's decision date was Jan 15, 2026, under product code OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance).

Who makes the BIOGRAPH One?

Siemens Healthineers AG, based in Forchheim, is the applicant of record for K253023.

How long did the K253023 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jan 15, 2026, 118 days later.

← All decisions in January 2026

Sources