# K970627: E. Cam Coincidence Mode (CM)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 4, 1997 after 197 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K981027: E.Cam Lso 311 Pet/Spect System (1998), 2 descendants of its own
- K040933: Ecat HRRT (2004), 0 descendants of its own
- K021633: Ecat Vision Pet Scanner, Models 3000 & 5000 (2002), 0 descendants of its own

## Indications for use
To detect or image the distribution of radionuclides in the body or organ using the following technique(s). Planar Imaging Whole Body Imaging Tomographic Imaging (SPECT) for non Positron emitter Positron imaging by coincidence Positron imaging without coincidence Positron Whole Body Imaging by coincidence

Source page: https://510kreport.com/device/K970627
Methodology: https://510kreport.com/methodology