Ortho Device Adaptix 3D Orthopedic Imaging System
by PAUSCH Medical GmbH 510(k)
Active
510(k) K221949
Overview
The Ortho Device Adaptix 3D Orthopedic Imaging System is a tomographic X-ray system designed to generate tomosynthesis images of human anatomy. It is intended for diagnostic purposes of the hand, elbow, and foot in patients of all ages, providing physicians with visualized information about anatomical structures.
This device is classified as a Class II system under regulation number 892.1740 and product code IZF. It has received FDA 510(k) clearance, as documented under K221949.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221949 | Date26 Jan 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IZF
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1740
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from PAUSCH Medical GmbH
Questions
What is the primary clinical use of the Adaptix 3D system?
The Adaptix 3D Orthopedic Imaging System is a tomographic X-ray system intended for diagnostic purposes. It is specifically designed to generate tomosynthesis images of the hand, elbow, and foot to provide physicians with visualized information about these anatomical structures.
Which patient populations can be imaged with this device?
The system is intended for use on patients of all ages. It provides diagnostic tomosynthesis imaging capabilities for the specified orthopedic regions regardless of the patient's age.
What is the regulatory status of the Adaptix 3D system?
The Adaptix 3D Orthopedic Imaging System has received FDA 510(k) clearance under K221949. It is classified as a Class II system under regulation number 892.1740 and product code IZF.