IntraOs 70
by Blue X Imaging Srl 510(k)
Active
510(k) K031118
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031118 | Date8 Jul 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EHD
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The IntraOs 70 is an extraoral X-ray unit with a built-in timer, designed for dental imaging. It captures high-quality radiographic images of dental structures, aiding in diagnostic assessments for oral health conditions.
This device is intended for use in dental clinics and offices, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K031118) as a Class II device (regulation number 872.1800) and is not classified as MRI-safe. The system requires proper installation, maintenance, and storage as outlined in its service manuals.
Other devices from Blue X Imaging Srl
Questions
AI-generated answers, 19 Sep 2026
What types of dental structures can the IntraOs 70 capture, and how does this benefit diagnostic assessments?
The IntraOs 70 is an extraoral X-ray unit specifically designed to capture high-quality radiographic images of dental structures. This includes detailed visualization of teeth, jaws, and surrounding bone, which aids in diagnosing oral health conditions such as cavities, gum disease, impacted teeth, or bone abnormalities. By providing clear and precise images, it helps clinicians make accurate assessments and treatment plans.
Is the IntraOs 70 intended for single-use or reusable applications in a dental clinic?
The IntraOs 70 is supplied as a reusable medical instrument, meaning it is designed for repeated use in dental clinics after proper cleaning, maintenance, and sterilization as outlined in its service manuals. This makes it a cost-effective solution for ongoing dental imaging needs.
What regulatory pathway does the IntraOs 70 follow, and what does this mean for its use in the U.S.?
The IntraOs 70 follows the FDA 510(k) clearance pathway and is classified as a Class II device under regulation number 872.1800. This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA standards for safety and effectiveness. Clinicians can rely on its compliance with U.S. regulatory requirements for dental X-ray imaging.
Does the IntraOs 70 require any special installation or maintenance, and how should it be stored?
Yes, the IntraOs 70 requires proper installation, maintenance, and storage as specified in its service manuals. Since it is a reusable device, it must be cleaned, serviced, and stored in a way that ensures optimal performance and longevity. Following manufacturer guidelines will help maintain image quality and device reliability over time.
Is the IntraOs 70 compatible with MRI environments, and what precautions should be taken during use?
The IntraOs 70 is explicitly not classified as MRI-safe, meaning it should never be used in or near an MRI environment. Since it is an X-ray unit, it contains components that could interfere with MRI systems or pose risks to patients undergoing MRI scans. Clinicians must ensure it is stored and used in non-MRI areas to avoid complications.