FDA 510(k) clearance · back to tracker

SubtleHD-CT (1.x)

Subtle Medical, Inc. cleared K254120 on 2026-05-15, decision: substantially equivalent

K-number

K254120

Sponsor

Subtle Medical, Inc.

Device

SubtleHD-CT (1.x)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-15

Product code

QIH

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2050

Official FDA record

Open K254120on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K254120 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.