# K121296: Interventional Workspot

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 2, 2013 after 247 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: 9 generations back to K890348 (1989). 52 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031836: Philips Fresco Release 1, Philips Medical Systems North America Co. (2003) Summary page 1.
- K040254: Integris 3D-RA, Release 4.2, Philips Medical Systems North America Co. (2004) Summary page 1.
- K042334: Allura 3D-CA, Release 1, Philips Medical Systems North America Co. (2004) Summary page 1.
- K060749: Xperct, Philips Medical Systems North America Co. (2006) Summary page 1.
- K111245: Heartnavigator Release 1, Philips Medical Systems Nederland B.V. (2011) Summary page 2.

## Most influential descendants
- K181177: Interventional Workspot (2018), 0 descendants of its own

## Indications for use
1.1 Device Description The interventional workspot is a software platform to host Interventional Tools. It provides common functionalities (e.g. import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the interventional procedure. 1.2 Medical Purpose The Interventional Workspot has the following medical purpose: - import, export, and store digital clinical images. - manage the patient information associated with those images: 1.3 Patient Population Not applicable because Interventional Workspot is only a hosting platform. 1.4 Intended Operator Profile The operator of Interventional Workspot has basic understanding of the operating principle of medical computer software. 1.5 Clinical Environment The software can be used in the control room and in the exam room of an interventional suite and/or operating room.

Source page: https://510kreport.com/device/K121296
Methodology: https://510kreport.com/methodology