WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / May 2026 / K254120

510(k) cleared

SubtleHD-CT (1.x)

Subtle Medical, Inc. · May 15, 2026 · K254120

FDA cleared the SubtleHD-CT (1.x) from Subtle Medical, Inc. on May 15, 2026 under K254120, a traditional 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 Dec 19, 2025. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Subtle Medical, Inc. has one other decision in the tracker over the last 12 months: K254013 (SubtleHD-PET (1.x)).

Questions & Answers

What did FDA clear under K254120?

K254120 is the FDA 510(k) for SubtleHD-CT (1.x), submitted by Subtle Medical, Inc.. FDA's decision date was May 15, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the SubtleHD-CT (1.x)?

Subtle Medical, Inc., based in Menlo Park, CA, is the applicant of record for K254120.

How long did the K254120 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 15, 2026, 147 days later.

← All decisions in May 2026

Sources