# K021633: Ecat Vision Pet Scanner, Models 3000 & 5000

- Pathway: 510(k) (Traditional)
- Applicant: Cti Pet Systems, Inc.
- Decided: Aug 14, 2002 after 89 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: 2 generations back to K914350 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962797: Ecat Exact & Ecat Exact HR+, Cti Pet Systems, Inc. (1996) Summary page 1.
- K981027: E.Cam Lso 311 Pet/Spect System, Cti Pet Systems, Inc. (1998) Summary page 2.
- K002715: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000)

## Indications for use
CPS ECAT Vision 3000 and ECAT Vision 5000 positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to detect the location and distribution of injected positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data.

Source page: https://510kreport.com/device/K021633
Methodology: https://510kreport.com/methodology