# K073696: Veraviewepocs

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Apr 8, 2008 after 99 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973598 (1997). 10 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030699: Veraviewepocs Panoramic/Cephalometric X-Ray Unit with  Cephalometric, J. Morita Mfg. Corp. (2003) Summary page 1.
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf, J. Morita USA, Inc. (2005) Summary page 1.
- K060328: Planmeca Promax 3D, Planmeca Oy (2006) Summary page 1.

## Most influential descendants
- K093683: Orthopantomograph OP300 (2010), 21 descendants of its own
- K111231: Panoura 18S (2011), 11 descendants of its own
- K122018: OP300 (2012), 8 descendants of its own
- K133544: OP300 (2014), 7 descendants of its own
- K122199: PREXION3D Eclipse (2013), 6 descendants of its own

## Indications for use
The Veraviewepocs is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull including the ENT and dento-maxillofacial areas, by exposing an X-ray image receptor to ionizing radiation. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K073696
Methodology: https://510kreport.com/methodology
