Sopix Inside, SOPIX2 Inside

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K140013 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner

  Class II

  CE/MDR FDA 510(k) K151053 Active Cleared 31 Jul 2015

• Sopix

  Class II

  FDA 510(k) K142995 Active Cleared 17 Aug 2015

• S698 Symbioz flow

  Class II

  FDA 510(k) K153367 Active Cleared 17 Jun 2016

• Are the Sopix Inside and Sopix2 Inside systems designed for single-use or reusable applications in a dental setting?

  The Sopix Inside and Sopix2 Inside are reusable digital extraoral X-ray systems. They are intended for use in dental offices and clinics, where the portable X-ray source and imaging components are designed to be cleaned and reused between patients. No specific sterility requirements are mentioned in the data, so standard dental office disinfection protocols should apply.

• What types of dental imaging capabilities do the Sopix Inside and Sopix2 Inside systems provide?

  Both systems are digital extraoral X-ray devices, meaning they capture images of dental structures from outside the mouth. While the primary focus is extraoral imaging, they also support intraoral imaging capabilities, making them versatile for diagnosing and planning treatments for oral health conditions. This includes capturing full-mouth views and detailed images of teeth, jaws, and surrounding structures.

• How are these devices authorized for use in the United States and Europe?

  The Sopix Inside and Sopix2 Inside are authorized through the FDA 510(k) pathway in the U.S., where they were determined to be substantially equivalent to a predicate device. In the EU, they comply with the Medical Device Regulation (MDR), ensuring they meet stringent safety, performance, and regulatory requirements for Class II devices. No additional approvals or certifications are mentioned beyond these pathways.

• Are there different models or sizes available for the Sopix Inside and Sopix2 Inside systems?

  The data does not specify distinct sizes or physical configurations for the Sopix Inside and Sopix2 Inside systems beyond their classification as portable digital extraoral X-ray systems. However, the OpenFDA registration numbers suggest multiple accessory or sensor variants may exist (e.g., different sensor types or positioning devices), but these are not detailed in the provided information. Clarification from the manufacturer would be needed for exact model differences.

• What storage or handling requirements should be followed for these reusable systems?

  Since the Sopix Inside and Sopix2 Inside are reusable, they should be stored in a clean, dry environment when not in use to prevent damage or contamination. The manufacturer likely provides specific cleaning and maintenance instructions (not included here), but standard dental equipment protocols—such as avoiding extreme temperatures, moisture, or physical stress—should apply. No MRI safety or sterility guarantees are mentioned, so users must follow facility-specific protocols for disinfection and storage.