Imasight 4600 Digital Radiography Sensor

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

510(k) Number

K092307 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• What types of patients is the Imasight 4600 Digital Radiography Sensor designed to accommodate, and how does this affect its use in a radiology department?

  The Imasight 4600 Digital Radiography Sensor is explicitly designed for use with both adult and pediatric patients, making it versatile for a broad range of radiographic imaging needs in radiology departments. This versatility ensures that the device can be reliably deployed for general diagnostic imaging across different patient demographics, including children, without requiring additional specialized configurations.

• Is the Imasight 4600 Digital Radiography Sensor a single-use or reusable device, and what does this mean for maintenance and operational workflow?

  The Imasight 4600 is supplied as a reusable system, meaning it is intended for repeated use in radiology settings after proper cleaning, maintenance, and calibration. This design reduces waste and operational costs but requires adherence to manufacturer guidelines for cleaning, sterilization (if applicable), and technical upkeep to ensure consistent imaging accuracy and compliance with regulatory standards.

• How is the regulatory clearance for the Imasight 4600 Digital Radiography Sensor structured, and what does the K-number K092307 indicate?

  The Imasight 4600 holds FDA 510(k) clearance under the K-number K092307, which confirms it is classified as a Class II medical device and deemed *substantially equivalent* to a legally marketed predicate device. This clearance was granted through a traditional review process by the FDA’s Radiology (RA) Advisory Committee, ensuring it meets regulatory standards for stationary X-ray systems used in diagnostic radiography.

• Does the Imasight 4600 Digital Radiography Sensor require any special handling or storage conditions to maintain its performance?

  While the provided data does not specify sterility requirements or MRI safety considerations, the device’s reusable nature implies it must be stored in a clean, dry environment to prevent contamination or damage. Proper handling, calibration, and adherence to manufacturer instructions are critical to maintaining imaging quality and ensuring longevity. No explicit storage temperature or humidity guidelines are mentioned, so facility-specific protocols should align with general medical device maintenance standards.

• What types of radiographic images can the Imasight 4600 Digital Radiography Sensor capture, and how does its stationary design benefit clinical workflows?

  The Imasight 4600 is designed for capturing high-resolution radiographic images in stationary X-ray systems, suitable for general diagnostic purposes in radiology. Its stationary design eliminates the need for portable or mobile setups, allowing for consistent positioning and faster workflow integration in fixed radiology departments. This setup is particularly advantageous for routine imaging of adults and pediatric patients, where stability and repeatability are essential for accurate diagnostics.