SubtleHD-PET (1.x)— 510(k) K254013
Substantially EquivalentSubtle Medical, Inc.
FDA 510(k) clearance K254013 for SubtleHD-PET (1.x), Substantially Equivalent on 2026-05-14. Applicant: Subtle Medical, Inc.. Device class: 2.
Summary
SubtleHD-PET, listed as 1.x, is from Subtle Medical and is filed under LLZ, radiological image processing systems.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Subtle Medical filed from Menlo Park, California. Review took 150 calendar days (December 15, 2025 to May 14, 2026).
Clearance details
- Applicant
- Subtle Medical, Inc.
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code LLZ
view allMore clearances from Subtle Medical, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.