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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 / K252988

510(k) cleared

ChartCheck (RADCH V1.6)

Radformation, Inc. · Jan 5, 2026 · K252988

FDA cleared the ChartCheck (RADCH V1.6) from Radformation, Inc. on Jan 5, 2026 under K252988, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 18, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Radformation, Inc. has 4 other decisions in the tracker over the last 12 months: K262452 (AutoContour (RADAC V6)), K253962 (ClearCheck (RADCC V2.7)), K260509 (AutoContour (RADAC V5)), K252863 (ClearCalc Model RADCA V2.6).

Questions & Answers

What did FDA clear under K252988?

K252988 is the FDA 510(k) for ChartCheck (RADCH V1.6), submitted by Radformation, Inc.. FDA's decision date was Jan 5, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the ChartCheck (RADCH V1.6)?

Radformation, Inc., based in New York, NY, is the applicant of record for K252988.

How long did the K252988 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Jan 5, 2026, 109 days later.

← All decisions in January 2026

Sources