# K013521: Gemini Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Nov 7, 2001 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K002715 (2000). 2 ancestors in all.
88 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010641: GE CT-Pet System, Ge Medical Systems, Inc. (2001) Summary page 2.
- K002715: Ecat Pet Scanner, Cti Pet Systems, Inc. (2000) Summary page 2.

## Most influential descendants
- K032036: Gemini 16 (2003), 87 descendants of its own
- 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

## Recalls of this device
- Aug 21, 2012 · Class II · Z-2451-2012: A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.
- Mar 11, 2005 · Not classified · Z-1417-05: 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
GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals 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 “fused” 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. GEMINI can provide CT data suitable for use in attenuation correction.

Source page: https://510kreport.com/device/K013521
Methodology: https://510kreport.com/methodology