Image-X System
510(k) K012355
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012355 | Date9 Aug 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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 Image-X System is an extraoral dental X-ray unit designed for capturing radiographic images of teeth, jaws, and oral structures. Classified as a Unit, X-Ray, Extraoral With Timer, it emits controlled X-ray radiation to produce detailed diagnostic images used in dental evaluations.
This device is intended for use in dental settings and is supplied as a reusable medical instrument. It is not sterile upon packaging and must be cleaned and maintained according to manufacturer guidelines. The system is regulated under FDA 510(k) clearance (K012355) and adheres to the regulatory requirements outlined in 21 CFR 872.1800. Multiple FEI numbers (e.g., 3013099020) correspond to its various configurations and components.
Questions
AI-generated answers, 19 Sep 2026
Is the Image-X System intended for single-use or can it be reused in a clinical setting?
The Image-X System is designed as a reusable medical instrument. Since it is not sterile upon packaging, it must be cleaned and maintained according to the manufacturer’s guidelines before each use to ensure safety and proper function.
What types of dental images can the Image-X System capture, and where is it primarily used?
The Image-X System is an extraoral dental X-ray unit specifically designed to capture radiographic images of teeth, jaws, and oral structures. It is intended for use in dental settings, such as clinics and offices, where detailed diagnostic imaging is required for comprehensive dental evaluations.
How is the Image-X System regulated, and what does this mean for purchasing or using it?
The Image-X System is regulated under the FDA’s 510(k) clearance process, with the clearance number K012355. This means it has been determined to be substantially equivalent to a legally marketed device and adheres to regulatory standards outlined in 21 CFR 872.1800. Purchasers or users should ensure compliance with manufacturer instructions and applicable local regulations.
Does the Image-X System come in multiple configurations, and if so, how might this affect my purchase decision?
Yes, the Image-X System includes multiple configurations and components, each corresponding to different FEI (Final Establishment Identification) numbers. These variations may offer flexibility in terms of features or specifications, so reviewing the exact FEI numbers and their associated details can help ensure the system meets your specific clinical or operational needs.
How should the Image-X System be stored, and are there any special considerations for its maintenance?
While the device data does not specify storage instructions, as a reusable medical instrument, the Image-X System should be stored in a clean, dry environment to prevent damage or contamination. Maintenance should follow the manufacturer’s guidelines to ensure proper functionality, including regular cleaning and inspection before each use.