# K003241: Ecat Pet Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Cti Pet Systems, Inc.
- Decided: Dec 13, 2000 after 57 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K032063: Pem 2400 Pet Scanner (2003), 2 descendants of its own
- K090553: Naviscan Pemflex Solo II High Resolution Pet Scanner (2009), 1 descendant of its own
- K214062: Radialis PET Camera (2022), 0 descendants of its own
- K042428: SCEPTREP3 Pet/CT (2004), 0 descendants of its own

## Recalls of this device
- Mar 28, 2006 · Not classified · Z-0712-06: There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.
- Apr 5, 2005 · Not classified · Z-0819-05: Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during tra

Source page: https://510kreport.com/device/K003241
Methodology: https://510kreport.com/methodology