# K981027: E.Cam Lso 311 Pet/Spect System

- Pathway: 510(k) (Traditional)
- Applicant: Cti Pet Systems, Inc.
- Decided: Jun 8, 1998 after 81 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
Longest line of descent: 1 generation back to K914350 (1991). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 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.
- K970627: E. Cam Coincidence Mode (CM), Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K914350: Icon Computer System, Siemens Gammasonics, Inc. (1991) Summary page 1.
- K962797: Ecat Exact & Ecat Exact HR+, Cti Pet Systems, Inc. (1996) Summary page 1.
- K974256: Ecat Pet Scanners, Cti Pet Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
The Siemens/CPS E.CAM LSO 311 PET/SPECT System is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures.

Source page: https://510kreport.com/device/K981027
Methodology: https://510kreport.com/methodology