# K982387: E.Cam Extra High Energy Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 6, 1998 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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 techinique(s): A. Planar Imaging B. Whole Body Imaging C. Tomographic Imaging (SPECT) for non Positron emitter D. Positron imaging by coincidence E. Positron imaging with out coincidence — Camera range increases to 588 keV

Source page: https://510kreport.com/device/K982387
Methodology: https://510kreport.com/methodology