# K241329: SubtleSYNTH (1.x)

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: Jul 11, 2024 after 62 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K201616 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201616: SyMRI, Syntheticmr AB (2020) Summary page 4.

## Indications for use
SubtleSYNTH is a software as a medical device consisting of a software machine learning algorithm that synthesizes a SynthSTIR contrast image of a case from T1-weighted and T2-weighted spine MR images.

Source page: https://510kreport.com/device/K241329
Methodology: https://510kreport.com/methodology