# K080961: NM Application Suite

- Pathway: 510(k) (Traditional)
- Applicant: Philips Nuclear Medicine, Inc.
- Decided: Apr 18, 2008 after 14 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: 3 generations back to K892358 (1989). 4 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 17 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.
- K061029: Jetstream Workspace, Adac Laboratories (2006) Summary page 1.

## Most influential descendants
- K111336: EBW NM 2.0 (2011), 9 descendants of its own
- K162955: Multi-Modality Tumor Tracking (MMTT) application (2016), 5 descendants of its own
- K210831: OnQ Neuro (2021), 3 descendants of its own
- K151212: Ziostation2 (2015), 2 descendants of its own
- K250416: GBrain MRI (2025), 1 descendant of its own

## Recalls of this device
- Sep 15, 2011 · Not classified · Z-0182-2012: A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated eject

## Indications for use
A nuclear medicine image display and processing application suite 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 NM Application Suite should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Source page: https://510kreport.com/device/K080961
Methodology: https://510kreport.com/methodology