Identity
- Trade Name
- RSM 2430C EUDAMEDRoseM FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Flat-Panel Digital X-ray Detector EUDAMEDThe RSM 2430C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used. FDA UDI
- Model / Reference
- RSM 1824C EUDAMEDRSM 2430C EUDAMEDFDA UDI
- Description
- The RSM 2430C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018401903 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000184DMXXXXXXXXW7 EUDAMED
- Direct Marketing DI
- 08800018401903 EUDAMED
- 510(k) Number
- K170930 FDA UDI
- FDA Product Code
- MUE FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Indirect flat panel x-ray detector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1715 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
Rsm 2430c by DRTECH Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000184DMXXXXXXXXW7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DRTECH Corporation
- EUDAMED SRN
- KR-MF-000012441
- Authorised Representative
- DRTECH Europe GmbH DE-AR-000011974
Sources (2)
- EUDAMED f1f53d69-b935-4cda-b654-7fba2f84d31e 61 fields · synced Jul 23, 2026
- FDA UDI 59f351a1-473f-402e-81f9-64c58914c60b 34 fields · synced May 30, 2026