# K032036: Gemini 16

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jul 11, 2003 after 10 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: 4 generations back to K930090 (1993). 12 ancestors in all.
87 later devices descend from it; 2 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013521: Gemini Imaging System, Adac Laboratories (2001) Summary page 2.
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K041955: Gemini Pet/CT Imaging System (2004), 65 descendants of its own
- K062650: EP Navigator Software (2006), 49 descendants of its own
- K101311: EP Navigator R3 (2010), 41 descendants of its own
- K111245: Heartnavigator Release 1 (2011), 39 descendants of its own
- K121781: Echonavigator Release 1 (2012), 32 descendants of its own

## Recalls of this device
- May 1, 2008 · Class II · Z-0197-2016: The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
- Mar 11, 2005 · Not classified · Z-1418-05: When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.

## Indications for use
The device is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). The device produces attenuation and non-attenuation corrected images of the distribution of PET radiophannaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a “fbsed” (overlaid in the same spatial orientation) format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. The device can provide CT data suitable for use in attenuation correction.

Source page: https://510kreport.com/device/K032036
Methodology: https://510kreport.com/methodology