# K032063: Pem 2400 Pet Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Pem Technologies
- Decided: Aug 18, 2003 after 46 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
Longest line of descent: 1 generation back to K914267 (1992). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914267: GE 4096 Plus & GE 2048, GE Medical Systems (1992) Summary page 1.
- K003241: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000)
- K002715: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000)

## Most influential descendants
- 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

## Recalls of this device
- Jun 19, 2008 · Not classified · Z-2229-2008: This field correction is being initiated as a result of the firm's investigation into a report from a user indicating that the motorized compression exceeded 25 pounds of compression force during the 
- Aug 1, 2007 · Not classified · Z-0041-2008: Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammog

## Indications for use
The PEM 2400 PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Source page: https://510kreport.com/device/K032063
Methodology: https://510kreport.com/methodology