# K061029: Jetstream Workspace

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: May 1, 2006 after 17 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K892358 (1989). 3 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993946: Pegasys Ultra, Adac Laboratories (2000) Summary page 1.
- K042880: Jetstream Workspace, Adac Laboratories (2004) Summary page 1.

## Most influential descendants
- 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
- K162955: Multi-Modality Tumor Tracking (MMTT) application (2016), 5 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.

## Indications for use
JETStream® Workspace is a nuclear medicine image display and processing workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The JETStream® Workspace system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Source page: https://510kreport.com/device/K061029
Methodology: https://510kreport.com/methodology