# K090403: Autospect

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Mar 31, 2009 after 42 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: 2 generations back to K992317 (1999). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042903: Autospecs, Adac Laboratories (2004) Summary page 2.

## Most influential descendants
- K111336: EBW NM 2.0 (2011), 9 descendants of its own
- K162955: Multi-Modality Tumor Tracking (MMTT) application (2016), 5 descendants of its own
- K210831: OnQ Neuro (2021), 3 descendants of its own
- K151212: Ziostation2 (2015), 2 descendants of its own
- K250416: GBrain MRI (2025), 1 descendant of its own

## Recalls of this device
- Mar 4, 2016 · Class II · Z-1504-2016: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for ot
- Mar 4, 2016 · Class II · Z-1505-2016: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for ot

## Indications for use
AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

Source page: https://510kreport.com/device/K090403
Methodology: https://510kreport.com/methodology