# K031118: Intraos 70

- Pathway: 510(k) (Traditional)
- Applicant: Blue X Imaging Srl
- Decided: Jul 8, 2003 after 91 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Explor-X 70: named in the summary without a submission number

## Most influential descendants
- K222274: Fona XDC (2022), 0 descendants of its own

## Indications for use
The IntraOs 70 (with Autoset Timer) is intended for the dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth. Such a device makes use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.

Source page: https://510kreport.com/device/K031118
Methodology: https://510kreport.com/methodology