Identifiers
- 510(k) Number
- K102474 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 FLAATZ 750E is a solid state X-ray imager, also known as a flat panel or digital imager, used for radiographic image acquisition. It is a direct digital imaging device that utilizes selenium technology to produce high-quality, clear images.
The FLAATZ 750E is supplied as part of the APEX DR product line and is authorized under FDA 510(k) clearance with number K102474. It is a Class II device regulated under number 892.1680 and is manufactured by Drtech Corp. in Seongnam-Shi, Gyeonggi-Do, South Korea.
Frequently asked questions
What is the FLAATZ 750E used for?
The FLAATZ 750E is a solid state X-ray imager used for radiographic image acquisition. It is a direct digital imaging device that utilizes selenium technology to produce high-quality, clear images for diagnostic purposes.
How is the FLAATZ 750E supplied?
The FLAATZ 750E is supplied as part of the APEX DR product line. It is manufactured by Drtech Corp. in Seongnam-Shi, Gyeonggi-Do, South Korea, and is authorized under FDA 510(k) clearance with number K102474.
What is the regulatory classification of the FLAATZ 750E?
The FLAATZ 750E is a Class II device regulated under number 892.1680. It received FDA 510(k) clearance with number K102474 on March 4, 2011, after being submitted on August 30, 2010.
What technology does the FLAATZ 750E use for imaging?
The FLAATZ 750E utilizes selenium technology as a direct digital imaging device. This technology allows it to produce high-quality, clear radiographic images without the need for traditional film or other intermediate steps.
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: FLAATZ FLAATZ 750E by DRTECH - Komachine Supplier Profile and Product List, FLAATZ 750E (K102474) — FDA 510 (k) | Innolitics, DRTECH FLAATZ - Control-X Medical - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102474 | Class II | Active |
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Manufacturer
- Manufacturer
- Drtech Corp.
Sources (1)
- FDA 510(k) K102474 24 fields · synced Sep 22, 2026