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

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

510(k) Number

K151053 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Sopix

  Class II

  FDA 510(k) K142995 Active Cleared 17 Aug 2015

• Sopix Inside, SOPIX2 Inside

  Class II

  CE/MDR FDA 510(k) K140013 Active Cleared 5 Sep 2014

• S698 Symbioz flow

  Class II

  FDA 510(k) K153367 Active Cleared 17 Jun 2016

• What types of dental imaging can the PSPIX 2 Scanner perform, and how does it differ from traditional film-based systems?

  The PSPIX 2 Scanner is designed specifically for intraoral and panoramic dental radiography, capturing high-resolution digital images using removable imaging plates. Unlike traditional film-based systems, it eliminates the need for chemical processing and provides immediate digital outputs, improving efficiency and diagnostic clarity in dental clinics. The removable plates (sizes 0 through 3) adapt to different imaging needs, offering flexibility for various dental procedures.

• Are the imaging plates for the PSPIX 2 Scanner reusable or single-use, and how should they be handled?

  The imaging plates for the PSPIX 2 Scanner are single-use only. They must be stored in protective packaging and handled according to the manufacturer’s guidelines to maintain sterility and optimal performance. After use, they are processed within the scanner and then discarded, ensuring no cross-contamination between patients.

• What regulatory approvals does the PSPIX 2 Scanner hold, and how does this affect its use in dental practices?

  The PSPIX 2 Scanner holds FDA 510(k) clearance and EU MDR authorization, confirming its compliance with U.S. and European medical device regulations. This means it is legally marketable in both regions for its intended use in dental radiography, subject to adherence to local guidelines and manufacturer instructions. The approvals do not dictate clinical indications but validate its safety and performance for dental imaging.

• How many sizes of imaging plates are available for the PSPIX 2 Scanner, and what determines the appropriate plate size for a procedure?

  The PSPIX 2 Scanner supports four imaging plate sizes (0 through 3), each designed for different anatomical regions or imaging requirements. The appropriate size depends on the specific dental procedure—smaller plates (e.g., Size 0) may be used for precise intraoral shots, while larger plates (e.g., Size 3) could accommodate broader panoramic views. The manufacturer’s documentation should guide selection based on clinical needs.

• Is the PSPIX 2 Scanner itself reusable, and what maintenance or care is required to ensure its longevity?

  Yes, the PSPIX 2 Scanner itself is reusable and built for long-term use in dental clinics. To maintain its performance, it should be cleaned and serviced according to the manufacturer’s instructions, which likely include regular calibration and component checks. Proper handling of the removable imaging plates (single-use) also contributes to the scanner’s reliability. Always follow the provided user manual for detailed care guidelines.