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FDA 510(k)

SubtleHD-CT (1.x)

K-Number: K254120 · 2026-05-15

ApplicantSubtle Medical, Inc.
Decision Date2026-05-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SubtleHD-CT (1.x) is a medical device manufactured by Subtle Medical, Inc.. It received FDA 510(k) clearance on 2026-05-15 under approval number K254120. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SubtleHD-CT (1.x)?

SubtleHD-CT (1.x) is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Subtle Medical, Inc.. The 510(k) number is K254120.

When was SubtleHD-CT (1.x) approved by the FDA?

SubtleHD-CT (1.x) received FDA 510(k) clearance on 2026-05-15, under approval number K254120.

What company makes SubtleHD-CT (1.x)?

SubtleHD-CT (1.x) is manufactured by Subtle Medical, Inc..

What is the FDA product code for SubtleHD-CT (1.x)?

The FDA product code for SubtleHD-CT (1.x) is QIH.

Other Devices by Subtle Medical, Inc.

K254013SubtleHD-PET (1.x)

Related Devices (Code: QIH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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