# K041218: Griffin Spect/CT Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: May 24, 2004 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 11 (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.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031705: Skylight Imaging System, Adac Laboratories (2003) Summary page 1.
- K012009: MX8000 Idt CT System, Marconi Medical Systems, Inc. (2001)

## Most influential descendants
- K051351: Precedence Spect/CT Imaging System (2005), 0 descendants of its own

## Recalls of this device
- Dec 15, 2017 · Class II · Z-0513-2018: During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator m
- Dec 15, 2017 · Class II · Z-0514-2018: During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator m
- Mar 6, 2015 · Class II · Z-1778-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh
- Mar 6, 2015 · Class II · Z-1779-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh
- Sep 27, 2011 · Not classified · Z-0255-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0257-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0256-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Sep 27, 2011 · Not classified · Z-0258-2012: A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Dec 28, 2010 · Not classified · Z-1549-2011: Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
- Dec 28, 2010 · Not classified · Z-1550-2011: Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
- Sep 28, 2007 · Not classified · Z-0676-2008: Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements

## Indications for use
Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Griffin may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Griffin Imaging System should only be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K041218
Methodology: https://510kreport.com/methodology