# K042880: Jetstream Workspace

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 3, 2004 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061029: Jetstream Workspace (2006), 26 descendants of its own
- K080961: NM Application Suite (2008), 12 descendants of its own
- K072468: Modification to D-Spect Cardiac Scanner System (2007), 10 descendants of its own
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K111336: EBW NM 2.0 (2011), 9 descendants of its own

## Recalls of this device
- Nov 19, 2020 · Class II · Z-0852-2021: A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

Source page: https://510kreport.com/device/K042880
Methodology: https://510kreport.com/methodology