# K002715: Ecat Pet Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Cti Pet Systems, Inc.
- Decided: Oct 31, 2000 after 61 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
271 later devices descend from it; 6 cite it directly.
7 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023190: E.Cam Computer / E.Soft Workstation (2002), 104 descendants of its own
- K013521: Gemini Imaging System (2001), 88 descendants of its own
- K032036: Gemini 16 (2003), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own

## Recalls of this device
- May 27, 2004 · Not classified · Z-0547-05: Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and
- Oct 2, 2003 · Not classified · Z-0106-04: CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.

Source page: https://510kreport.com/device/K002715
Methodology: https://510kreport.com/methodology