# K052434: Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Sep 27, 2005 after 21 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: 3 generations back to K952674 (1995). 3 ancestors in all.
16 later devices descend from it; 3 cite it directly.
9 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1999) Summary page 2.

## Most influential descendants
- K093514: Discovery Model NM/CT 670 (2009), 13 descendants of its own
- K153402: Discovery NM/CT 670 CZT (2016), 6 descendants of its own
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K190457: VERITON CT whole body SPECT/CT system (2019), 2 descendants of its own
- K111445: Discovery NM 630 (2011), 2 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
The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitate the localization of the NM activity in the patient anatomy.

Source page: https://510kreport.com/device/K052434
Methodology: https://510kreport.com/methodology