RSM 1824C with RConsole1
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- RSM 1824C EUDAMED
- Device Name
- Flat-Panel Digital X-ray Detector EUDAMED
- Model / Reference
- RSM 1824C EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800018405307 EUDAMED
- Basic UDI-DI
- 88000184DMXXXXXXXXW7 EUDAMED
- Direct Marketing DI
- 08800018405307 EUDAMED
- 510(k) Number
- K162670 FDA 510(k)
- FDA Product Code
- MUE FDA 510(k)
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1715 FDA 510(k)
- Regulation Number
- 892.1715 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The RSM 1824C with RConsole1 is a Full Field Digital X-Ray Mammographic System, designed for high-resolution imaging of breast tissue. It employs an indirect conversion digital flat panel detector with a cesium iodide (CsI) scintillator layer to convert X-ray photons into light, which is then transformed into electrical signals via PIN diodes in thin-film transistor (TFT) pixels. These signals are digitized for real-time viewing, storage, or transmission, enabling precise diagnostic imaging.
This system is supplied as a reusable medical device, intended for use in radiology settings, and is classified as Device Class II under FDA regulations. The RConsole1 integrates with the X-ray generator and detector, facilitating image acquisition and processing. It is compatible with analog system upgrades, including AEC (Automatic Exposure Control) functionality, and is designed for high-throughput workflows. The device holds FDA 510(k) clearance and MDR authorization, ensuring compliance with regulatory standards for mammographic imaging.
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: RSM 1824C with RConsole1 (K162670) — FDA 510 (k) | Innolitics, DRTECH, Drtech RSM 1824C With RConsole1 - allmed.wiki
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162670 | Class II | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
Sources (2)
- FDA 510(k) K162670 24 fields · synced Sep 18, 2026
- EUDAMED 9393de7b-0315-4ff7-8842-6737b104209a 61 fields · synced Jul 9, 2026