# K040142: Ensphere Tempo Jetstream Workspace Cardiology Module

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Feb 6, 2004 after 15 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 K892358 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K021669: Physician's Desktop Review, Adac Laboratories (2002) Summary page 1.

## Indications for use
ENSphereTM Tempo is a nuclear medicine image processing and display workstation that provides cardiology specific software applications used to process, analyze, and display medical images. The applications included with ENSphere Tempo may be used as a tool, by the Physician in interpreting Nuclear Cardiology procedures. ENSphere Tempo should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Source page: https://510kreport.com/device/K040142
Methodology: https://510kreport.com/methodology