# K130269: Ecat Scintron Pet

- Pathway: 510(k) (Traditional)
- Applicant: Miegmbh
- Decided: Apr 19, 2013 after 74 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 K962797 (1996). 2 ancestors in all.
1 later device descends 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)
- K962797: Ecat Exact & Ecat Exact HR+, Cti Pet Systems, Inc. (1996) Summary page 3.
- K002584: Ecat Accel Pet Scanner, Cti Pet Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K201807: Ancoris (2020), 0 descendants of its own

## Indications for use
The 'ECAT Scintron PET' integrated workstation is designed to acquire data, process and display images, by appropriated trained health care professionals, from ECAT EXACT and ECAT ACCEL PET scanners of CTI PET Systems via measuring the distribution of injected positron emitting radiopharmaceutical in humans for purpose of determining various metabolic and physiologic functions within the human body.

Source page: https://510kreport.com/device/K130269
Methodology: https://510kreport.com/methodology