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RADSpa
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref RADSpa®Model RADSpa® Version 4.2.4510(k) K141329
Identity
- Trade Name
- RADSpa EUDAMEDRADSpa® FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- RADSpa® EUDAMEDRADSpa RIS-PACS FDA UDI
- Model / Reference
- RADSpa® Version 4.2.4 EUDAMEDRADSpa® EUDAMEDRADSpa RIS-PACS 4.0 FDA UDI
- Description
- RADSpa RIS-PACS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908008302008 EUDAMEDFDA UDI
- Basic UDI-DI
- 8908008302RADSpaH6 EUDAMED
- Direct Marketing DI
- 08908008302008 EUDAMED
- 510(k) Number
- K141329 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RADSpa by Telerad Tech Private Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141329 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8908008302RADSpaH6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Telerad Tech Private Limited
- EUDAMED SRN
- IN-MF-000026224
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (3)
- EUDAMED 1c6c2b48-37db-4e44-84f9-7e41c844490f 85 fields · synced Jun 18, 2026
- FDA UDI 681b729c-5bfd-4c32-a788-92470ccdc29a 35 fields · synced May 30, 2026
- FDA 510(k) K141329 1 fields · synced May 18, 2026