# K201807: Ancoris

- Pathway: 510(k) (Traditional)
- Applicant: Miegmbh
- Decided: Aug 27, 2020 after 57 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 K002715 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130269: Ecat Scintron Pet, Miegmbh (2013) Summary page 4.
- K002584: Ecat Accel Pet Scanner, Cti Pet Systems, Inc. (2000) Summary page 4.
- K013504: Modification to: Ecat Lso Pet/CT Scanner, Cti Pet Systems, Inc. (2001) Summary page 4.

## Indications for use
The ‘ANCORIS’ PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring 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/K201807
Methodology: https://510kreport.com/methodology