# K040933: Ecat HRRT

- Pathway: 510(k) (Traditional)
- Applicant: Cti Pet Systems, Inc.
- Decided: Jun 7, 2004 after 59 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 1.

## Indications for use
CPS ECAT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

Source page: https://510kreport.com/device/K040933
Methodology: https://510kreport.com/methodology