# K063773: Volumetric  Tomography

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Dental, Inc.
- Decided: Jan 31, 2007 after 41 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K973642 (1997). 1 ancestor in all.
68 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973642: Orthopantomograph OP100 and Orthoceph OC100, Instrumentarium Imaging, Inc. (1997) Summary page 3.

## Most influential descendants
- K082350: PAX-500 (2008), 67 descendants of its own
- K090171: Computed Tomography X-Ray System, Pax-REVE3D (2009), 59 descendants of its own
- K102259: Dental Computed Tomography X-Ray System (2011), 42 descendants of its own
- K121412: Pax-FLEX3D, PHT-7000 (2012), 28 descendants of its own
- K122606: PHT-6500; PHT-60CFO; Pax-I3D (2012), 27 descendants of its own

## Indications for use
Volumetric Tomography is intended to be used for producing cross-sectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.

Source page: https://510kreport.com/device/K063773
Methodology: https://510kreport.com/methodology