# K992731: E.Cam Computer

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 10, 1999 after 89 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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: 1 generation back to K892358 (1989). 3 ancestors in all.
111 later devices descend from it; 5 cite it directly.
6 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952109: IP500 Nuclear Gamma Camera System, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K903315: ICON, Siemens Gammasonics, Inc. (1991) Summary page 1.
- K892358: Pegasys Nuclear Medicine Imaging Computer, Adac Laboratories (1989) Summary page 1.

## Most influential descendants
- K023190: E.Cam Computer / E.Soft Workstation (2002), 104 descendants of its own
- K041166: Siemens Enhanced Imaging System (2004), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own
- K082506: Symbia, Version 4.0 (2008), 83 descendants of its own

## Recalls of this device
- Apr 8, 2014 · Class II · Z-0914-2015: There is a potential for patient finger injury on the e.cam systems.

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: Planar Imaging Whole body imaging Tomographic imaging (SPECT) for non positron emitter Positron imaging by coincidence Positron imaging without coincidence up to 588 keV

Source page: https://510kreport.com/device/K992731
Methodology: https://510kreport.com/methodology