AeroDR System with P-21

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

510(k) Number

K113248 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Reguis Sigma

  Class II

  FDA 510(k) K103703 Active Cleared 2 Jun 2011

• Direct Digitizer, Regius Model 110

  Class II

  FDA 510(k) K071181 Active Cleared 30 May 2007

• Konica Minolta Xpress Digital Mammography System

  Class II

  FDA 510(k) K110717 Active Cleared 23 Dec 2011

• Direct Digitizer, Regius Model 210

  Class II

  FDA 510(k) K092717 Active Cleared 30 Oct 2009

• Direct Digitizer Regius Model 190

  Class II

  FDA 510(k) K052095 Active Cleared 3 Nov 2005

• Regius Unitea

  Class II

  FDA 510(k) K071436 Active Cleared 27 Jun 2007

See all devices from Konica Minolta Medical & Graphic, Inc. →

• What types of connectivity options are available for the AeroDR System with P-21 detector, and how does this affect its use in a radiology department?

  The AeroDR System with P-21 detector offers both wireless and wired connectivity options for the planar detector (AeroDR 1717HQ), allowing flexibility in setup depending on the radiology department’s infrastructure and workflow needs. This versatility ensures the system can be easily integrated into existing environments without requiring extensive modifications, enhancing convenience and adaptability for diagnostic imaging tasks.

• Is the AeroDR System with P-21 detector reusable or single-use, and what does this mean for maintenance and operational workflows?

  The AeroDR System with P-21 is not described as single-use or disposable, meaning the detector and system components are intended for repeated use in radiology departments. This design implies that maintenance protocols, such as cleaning, calibration, and periodic inspections, will be required to ensure consistent performance and image quality over time, aligning with standard practices for reusable medical imaging equipment.

• What specific model of detector is included with the AeroDR System, and how does it contribute to the imaging capabilities of the system?

  The AeroDR System is supplied with the P-21 detector model, which integrates with the planar detector (AeroDR 1717HQ) to capture high-resolution digital radiographic images. This combination enables precise and efficient diagnostic imaging, making it suitable for a range of radiology procedures where detailed visualization is critical. The P-21 model is explicitly designed for this system, ensuring compatibility and optimized performance.

• How was the regulatory pathway for the AeroDR System with P-21 determined, and what does this mean for healthcare providers considering this device?

  The AeroDR System with P-21 was cleared through the FDA’s 510(k) pathway, specifically classified as Substantially Equivalent (SESE) under the Radiology advisory committee (RA). This means the device was evaluated against a predicate (a previously cleared comparable product) to demonstrate safety and effectiveness, ensuring it meets FDA standards for stationary X-ray imaging systems. For healthcare providers, this clearance indicates the system has undergone rigorous review and is compliant with regulatory requirements for use in radiology departments.