# K042903: Autospecs

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: Oct 29, 2004 after 14 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992317 (1999). 1 ancestor in all.
13 later devices descend from it; 1 cites 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)
- K992317: Autospect Plus with Instill Motion Correction, Adac Laboratories (1999) Summary page 1.

## Most influential descendants
- K090403: Autospect (2009), 12 descendants of its own
- 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

## 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/K042903
Methodology: https://510kreport.com/methodology