# K023190: E.Cam Computer / E.Soft Workstation

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 24, 2002 after 29 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: 3 generations back to K952674 (1995). 8 ancestors in all.
104 later devices descend from it; 6 cite it directly.
7 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992731: E.Cam Computer, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K903315: ICON, Siemens Gammasonics, Inc. (1991) Summary page 1.
- K892358: Pegasys Nuclear Medicine Imaging Computer, Adac Laboratories (1989) Summary page 1.
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1999) Summary page 1.
- K002715: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000)

## Most influential descendants
- 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
- K131634: Symbia (2013), 66 descendants of its own
- K142006: Symbia 6.0 (2014), 65 descendants of its own

## Indications for use
E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques Planar Imaging Whole body itnaging Tomographic imaging (SPECT) for non positron emitter Positron imaging by coincidence Positron imaging without coincidence up to 588 keV Display and process nuclear medicine, PET and CT images

Source page: https://510kreport.com/device/K023190
Methodology: https://510kreport.com/methodology