# K172768: ZOOM

- Pathway: 510(k) (Traditional)
- Applicant: Zetta Medical Technologies, LLC
- Decided: Apr 24, 2018 after 223 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: 3 generations back to K922470 (1992). 3 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024028: Sharp View Image Enhancement System, Context Vision AB (2003) Summary page 4.

## Most influential descendants
- K191688: SubtleMR (2019), 20 descendants of its own
- K210999: SwiftMR (2021), 6 descendants of its own
- K203182: SubtleMR (2021), 6 descendants of its own
- K202404: BoneMRI (2021), 5 descendants of its own
- K221762: BoneMRI v1.4 (2022), 4 descendants of its own

## Indications for use
ZOOM Image Enhancement System is an image processing software that can be used for image enhancement in MRI images. Enhanced images will be sent to PACS server and exist in conjunction to the original images.

Source page: https://510kreport.com/device/K172768
Methodology: https://510kreport.com/methodology