I View and Imagen Sensor

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

510(k) Number

K162619 ↗

FDA Product Code

MUH

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• X-View 3D Pan/X-View 2D Pan

  Class II

  FDA 510(k) K222666 Active Cleared 10 Jul 2023

• RiX70 DC

  Class II

  FDA 510(k) K182206 Active Cleared 13 Sep 2018

• ReadeR, VieweR, QuickScan PSP

  Class II

  FDA 510(k) K160386 Active Cleared 10 Mar 2016

• I-View Gold and Imagen Gold Dental Sensors

  Class II

  FDA 510(k) K200625 Active Cleared 15 Apr 2020

• Is the I-View Intraoral Sensor designed for intraoral or extraoral use, and what does this mean for its placement during dental imaging?

  The I-View Intraoral Sensor is actually labeled as an extraoral digital X-ray imaging system, despite its name. This means the sensor is positioned *outside* the mouth (e.g., on the cheek or chin) rather than inside, capturing images of teeth and surrounding structures indirectly. The sensor’s design allows for high-resolution imaging while maintaining comfort and accessibility for patients.

• How is the I-View sensor system supplied, and what components are included in the package?

  The I-View system is supplied as a reusable sensor system paired with associated imaging software. The sensor itself is non-sterile and intended for single-use per patient, while the reusable components (e.g., the sensor housing or base unit) are designed for repeated use in dental settings. The package includes the sensor and the necessary software for image capture and evaluation.

• What storage or handling requirements apply to the I-View sensor, particularly given its non-sterile status?

  Since the I-View sensor is non-sterile, it must be handled and stored according to the manufacturer’s guidelines to prevent contamination. While the sensor itself is reusable, the single-use aspect refers to the disposable components (e.g., sensor covers or attachments) that interface with patients. Proper storage should follow standard dental equipment protocols to maintain functionality and hygiene.

• What regulatory pathway was followed for FDA clearance of the I-View sensor, and what does this imply for its safety and equivalence?

  The I-View sensor received FDA clearance via a Traditional 510(k) pathway, classified as substantially equivalent (SESE) under the Dental advisory committee (DE). This means the device was compared to a legally marketed predicate and determined to have the same intended use and technological characteristics, ensuring compliance with dental X-ray imaging standards. The clearance reflects adherence to safety and performance requirements for Class II devices.