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VariSeed 10.0
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref VariSeed 10.0510(k) K012017
Identity
- Trade Name
- VariSeed 10.0 EUDAMEDVariSeed FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- VariSeed EUDAMED
- Model / Reference
- VariSeed 10.0 EUDAMED10.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850800006067 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201007PQ EUDAMED
- 510(k) Number
- K232400 FDA UDI
- FDA Product Code
- MUJ FDA UDIKXK FDA UDI
- EMDN Code
- Z11010482 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.5730 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VariSeed 10.0 by Varian Medical Systems, Inc. — Class IIb — 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
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 | K012017 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K150636 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500201007PQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- FDA Applicant
- Varian Medical Systems
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED cb2a3c4f-99b7-42d7-b971-3e9f8bcbc706 85 fields · synced Jun 18, 2026
- FDA UDI 0f24ab32-f57b-4514-b839-56aa296707a1 33 fields · synced May 30, 2026
- FDA 510(k) K012017 1 fields · synced May 18, 2026