# K993946: Pegasys Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Mar 9, 2000 after 111 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: 1 generation back to K892358 (1989). 1 ancestor in all.
30 later devices descend from it; 5 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892358: Pegasys Nuclear Medicine Imaging Computer, Adac Laboratories (1989) Summary page 2.

## 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

## Indications for use
Pegasys Ultra is a nuclear medicine image processing and display 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 Pegasys Ultra system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Source page: https://510kreport.com/device/K993946
Methodology: https://510kreport.com/methodology