# K170273: Z-DOSE29

- Pathway: 510(k) (Traditional)
- Applicant: Zetta Medical Technologies, LLC
- Decided: Apr 28, 2017 after 88 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K982349 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143400: SOMATOM Definition AS/AS+, Siemens Medical Solutions USA, Inc. (2015) Summary page 4.
- K153331: SafeCT-29, Medic Vision Imaging Solutions (2016) Summary page 4.

## Indications for use
Z-DOSE29 Dose Check system is intended to provide dose check features to Computed Tomography systems. Z-DOSE29 software extracts CTDI values from CT host computer’s screen, compares it to predefined thresholds, and sends notification and alert messages to the CT scanner display monitor prior to scanning.

Source page: https://510kreport.com/device/K170273
Methodology: https://510kreport.com/methodology