# K961464: Select/SP

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Jul 3, 1996 after 77 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930090 (1993). 1 ancestor in all.
265 later devices descend from it; 3 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930090: Helicat, Elscint, Inc. (1993) Summary page 1.

## Most influential descendants
- K982060: Volumax CT Imaging System (1998), 264 descendants of its own
- K012009: MX8000 Idt CT System (2001), 263 descendants of its own
- K033326: Philips Plus Computed Tomography System (2003), 214 descendants of its own
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner (2004), 147 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own

## Recalls of this device
- Sep 28, 2012 · Class II · Z-0479-2013: Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliabi
- Sep 28, 2012 · Class II · Z-0906-2013: Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3
- Sep 11, 2012 · Class II · Z-0675-2013: Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automa

Source page: https://510kreport.com/device/K961464
Methodology: https://510kreport.com/methodology