# K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Aug 26, 1999 after 90 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952674 (1995). 2 ancestors in all.
120 later devices descend from it; 6 cite it directly.
10 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980959: Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K941223/S1: Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model. Number could not be read Summary page 1.

## Most influential descendants
- K023190: E.Cam Computer / E.Soft Workstation (2002), 104 descendants of its own
- K041166: Siemens Enhanced Imaging System (2004), 87 descendants of its own
- K063826: Syngo MI Applications 2007A (2007), 86 descendants of its own
- K072567: Symbia-E, Model 10275879 (2007), 85 descendants of its own
- K082506: Symbia, Version 4.0 (2008), 83 descendants of its own

## Recalls of this device
- Oct 14, 2014 · Class II · Z-0185-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. 
- Oct 14, 2014 · Class II · Z-0186-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. 
- Oct 14, 2014 · Class II · Z-0188-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. 
- Oct 14, 2014 · Class II · Z-0189-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. 
- Oct 14, 2014 · Class II · Z-0187-2015: GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being add
- Oct 14, 2014 · Class II · Z-0184-2015: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. 
- Jun 13, 2013 · Class I · Z-1787-2013: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
- Mar 6, 2012 · Class II · Z-1078-2013: Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and ope

## Indications for use
To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.

Source page: https://510kreport.com/device/K991841
Methodology: https://510kreport.com/methodology