OTC DDR System
by Konica Minolta Healthcare Americas, Inc 510(k)
Active
510(k) K221853
Overview
The OTC DDR System is a Stationary X-Ray System designed for dynamic digital radiography (DDR), enabling real-time imaging of moving anatomy. It captures motion-based studies such as pulmonary function and orthopedic kinematics with low-dose X-ray technology, facilitating retrospective diagnostic analysis.
This system is supplied as a ceiling-mounted X-ray tube with customizable software, allowing flexible positioning for patients in various states—lying, sitting, standing, or in wheelchairs/gurneys. It is intended for use in radiology settings, classified as a Class II device under FDA regulations (21 CFR 892.1680). The system is reusable and requires proper MRI safety compliance, though specific sterility or single-use details are not provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221853 | Date27 Jul 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Otc Ddr
- 510(k) Number
- FDA Product Code
- KPR
- FDA applicant
- Konica Minolta Healthcare Americas, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Konica Minolta Healthcare Americas, Inc
Questions
What types of medical studies or procedures is the OTC DDR System specifically designed to capture and analyze?
The OTC DDR System is designed for dynamic digital radiography (DDR), enabling real-time imaging of moving anatomy. It is particularly suited for capturing motion-based studies such as pulmonary function assessments and orthopedic kinematics, allowing retrospective diagnostic analysis of these dynamic processes.
How is the OTC DDR System positioned in relation to the patient, and what flexibility does it offer?
The OTC DDR System is supplied as a ceiling-mounted X-ray tube, which allows for flexible positioning of the patient in various states—such as lying, sitting, standing, or in wheelchairs/gurneys. This design accommodates diverse patient needs and clinical scenarios.
Is the OTC DDR System intended for single-use or reusable applications, and what are the implications for maintenance?
The OTC DDR System is explicitly described as a reusable device. This means it is designed for repeated use in clinical settings, though proper maintenance and cleaning protocols must be followed to ensure safety and functionality, particularly given its MRI safety compliance requirements.
What regulatory pathway was followed for the approval of the OTC DDR System, and what class does it fall under?
The OTC DDR System was cleared through the FDA’s 510(k) pathway, specifically classified as a Class II device under 21 CFR 892.1680. This designation indicates it has been determined to be substantially equivalent to a legally marketed predicate device and requires special controls for safety and effectiveness.
Does the OTC DDR System require any special handling or storage considerations beyond standard X-ray equipment?
While the provided data does not specify sterility or single-use requirements, the system’s reusable nature and MRI safety compliance imply that it must be stored in a clean, dry environment to prevent contamination and ensure proper functionality. Additionally, adherence to MRI safety guidelines is critical to avoid interference with other equipment in the vicinity.