Dicompacs DX-R With Flat Panel
by Oehm Und Rehbein GmbH 2 variants
510(k) K141440
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK141440 | Date29 Aug 2014 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- MQB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Dicompacs DX-R With Flat Panel is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed for digital radiographic imaging. It captures high-resolution X-ray images of human anatomy using a flat-panel detector, replacing traditional film/screen systems. This device is classified as a Class II medical device under regulatory frameworks, enabling precise diagnostic imaging for radiology applications.
This system is intended for use in radiology settings, including private practices, hospitals, and outpatient facilities. Supplied as a reusable device, it requires proper sterilization and maintenance protocols to ensure performance and safety. The Dicompacs DX-R With Flat Panel operates under FDA 510K and MDR authorizations, adhering to regulatory standards for stationary X-ray systems. Multiple model variants are available, each corresponding to specific registration numbers and technical configurations.
Other devices from Oehm Und Rehbein GmbH
Questions
AI-generated answers, 20 Sep 2026
What types of medical facilities can use the Dicompacs DX-R With Flat Panel, and why is it suitable for these settings?
The Dicompacs DX-R With Flat Panel is designed for radiology settings, including private practices, hospitals, and outpatient facilities. Its suitability stems from being a Solid State X-Ray Imager (Flat Panel/Digital Imager), which replaces traditional film/screen systems for capturing high-resolution digital radiographic images. This makes it versatile for diagnostic imaging across diverse clinical environments where precise X-ray imaging is required.
Is the Dicompacs DX-R With Flat Panel a single-use or reusable device, and what maintenance is required?
The Dicompacs DX-R With Flat Panel is a reusable device, meaning it is intended for repeated use in clinical settings. Since it is reusable, proper sterilization and maintenance protocols must be followed to ensure performance, safety, and compliance with regulatory standards. The manufacturer provides guidelines for cleaning and servicing to extend its operational lifespan.
How many model variants of the Dicompacs DX-R With Flat Panel are available, and how are they differentiated?
The Dicompacs DX-R With Flat Panel comes in multiple model variants, each corresponding to specific registration numbers (e.g., 3009717300, 3015223550, etc.) and technical configurations. These variants likely differ in specifications such as detector size, resolution, or compatibility with different X-ray systems, allowing facilities to select the model best suited to their diagnostic needs.
What regulatory pathways does the Dicompacs DX-R With Flat Panel follow, and how does this affect its use?
The Dicompacs DX-R With Flat Panel is authorized under FDA 510K and MDR (Medical Device Regulation) pathways, indicating it has undergone regulatory review to demonstrate substantial equivalence to existing devices in its class. This ensures compliance with safety and performance standards for stationary X-ray systems, allowing its use in radiology settings with confidence in its clinical efficacy and regulatory standing.