# K241350: Clarify DL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Israel, Functional Imaging
- Decided: Jan 3, 2025 after 235 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 12 generations back to K010641 (2001). 58 ancestors in all.
No later device cites it as a predicate yet.
6 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221680: Xeleris V Processing and Review System, GE Healthcare (2023) Summary page 5.
- K210173: StarGuide, GE Healthcare (2021) Summary page 5.

## Indications for use
Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images. Clarify DL may be used for patients of all ages.

Source page: https://510kreport.com/device/K241350
Methodology: https://510kreport.com/methodology