# K984332: Spectra VU 1000 Series Intraoral Camera, Spectra VU 2000 Series Intraoral Camera, Spectra VU Hddi SV I Intraoral Camera,

- Pathway: 510(k) (Traditional)
- Applicant: International Technology Concepts
- Decided: Apr 29, 1999 after 147 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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 K941452 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941452: Ultracam II, Dental Vision Direct, Inc. (1994) Summary page 1.

## Most influential descendants
- K002620: Suresmile System (2000), 0 descendants of its own

## Indications for use
The SpectraVu Family of Intraoral Cameras are intended for use in dentistry to provide a view of the oral cavity and contents as an aid in explaining and demonstrating conditions to patients. These also provide an enlarged view of areas for the dentist to better identify defects. Images can be stored for future reference. These cameras are not intended for use as an operative device. The camera and components are not manufactured to be sterile, however the metallic sleeve tip with the glass optical window is designed to be sterilized between uses, and/or may be protected by commercially available plastic disposable sleeves.

Source page: https://510kreport.com/device/K984332
Methodology: https://510kreport.com/methodology