Identifiers
- 510(k) Number
- K141271 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aerodr System 2 is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology. It is a second-generation digital radiography system designed for medical imaging applications.
The device is supplied as a reusable system and is regulated under FDA 510(k) clearance (K141271) as a Class II medical device. It is intended for use in healthcare facilities and has been determined to be substantially equivalent to a legally marketed predicate device.
Frequently asked questions
What is the Aerodr System 2 used for?
The Aerodr System 2 is a Solid State X-Ray Imager (Flat Panel/Digital Imager) used in radiology for medical imaging applications, designed as a second-generation digital radiography system for healthcare facilities.
Is the Aerodr System 2 reusable or single-use?
The Aerodr System 2 is supplied as a reusable system, meaning it is designed for multiple uses in clinical settings after appropriate cleaning and maintenance, not for single-use disposal.
What regulatory clearance does the Aerodr System 2 have?
The Aerodr System 2 is regulated under FDA 510(k) clearance (K141271) as a Class II medical device, having been determined substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AeroDR2-1417S - DR - Healthcare | KONICA MINOLTA, Konica minolta AeroDR System 2 Manuals | ManualsLib, KONICA MINOLTA AERODR SYSTEM OPERATION MANUAL Pdf Download, DR - Healthcare | KONICA MINOLTA, PDF AeroDR SYSTEM / Operation Manual SYSTEM
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141271 | Class II | Active |
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Manufacturer
- Manufacturer
- Konica Minolta, Inc.
Sources (1)
- FDA 510(k) K141271 24 fields · synced Sep 24, 2026