# K111336: EBW NM 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: May 24, 2011 after 12 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: 4 generations back to K892358 (1989). 8 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080961: NM Application Suite, Philips Nuclear Medicine, Inc. (2008) Summary page 1.
- K090403: Autospect, Philips Medical Systems (Cleveland), Inc. (2009) Summary page 2.

## Most influential descendants
- 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
- K181892: Ziostation2 (2018), 1 descendant of its own

## 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 structure. The data processed may be derived from any nuclear medicine camera. EBW NM 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

Source page: https://510kreport.com/device/K111336
Methodology: https://510kreport.com/methodology