FDA 510(k) clearance · back to tracker

SubtleHD-PET (1.x)

Subtle Medical, Inc. cleared K254013 on 2026-05-14, decision: substantially equivalent

K-number

K254013

Sponsor

Subtle Medical, Inc.

Device

SubtleHD-PET (1.x)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-14

Product code

LLZ

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.2050

Official FDA record

Open K254013on 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 K254013 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.

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Source

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