# K051980: DVT Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences Intl., Inc.
- Decided: Aug 19, 2005 after 29 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973598 (1997). 5 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003787: Newtom QR-DVT 9000, Aperio Services, LLC (2001) Summary page 2.
- K945375: Advantx Lca, GE Medical Systems (1995) Summary page 2.
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph, J. Morita USA, Inc. (2003) Summary page 2.

## Most influential descendants
- K063622: Finecube Dental CT (2007), 11 descendants of its own
- K122199: PREXION3D Eclipse (2013), 6 descendants of its own
- K161881: PreXion3D Excelsior (2016), 2 descendants of its own
- K152489: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (2016), 2 descendants of its own
- K072574: Alphard Cone Beam CT, Model X178 (2007), 2 descendants of its own

## Recalls of this device
- Dec 15, 2010 · Not classified · Z-3018-2011: Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply
- Oct 30, 2009 · Not classified · Z-0543-2010: overhead carriage drops quickly
- Mar 19, 2008 · Not classified · Z-1645-2008: incorrect scatter labeling

## Indications for use
The Imaging Sciences International Inc. DVT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.

Source page: https://510kreport.com/device/K051980
Methodology: https://510kreport.com/methodology