Solstice™ SRS Immobilization System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Medtec LLC
Identity
- Trade Name
- Solstice™ SRS Immobilization System FDA UDI
- Generic Name
- Radiological headrest FDA UDI
- Device Name
- Head support system for use with Type-S™ systems FDA UDI
- Model / Reference
- CHS04 EUDAMEDFDA UDIStereotactic Radiosurgery and Stereotactic Radiotherapy Devices EUDAMED
- Description
- Head support system for use with Type-S™ systems FDA UDI
Identifiers
- Catalog Number
- CHS04 FDA UDI
- Primary DI / UDI-DI
- 00841439112496 EUDAMEDFDA UDI
- Basic UDI-DI
- 8414391OC0019R01BX EUDAMED
- 510(k) Number
- K182079 FDA UDI
- FDA Product Code
- IYE FDA UDILNH FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Radiological headrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 12.61 Inch FDA UDIWidth — 10.35 Inch FDA UDI
Category: Radiological headrest
Solstice™ SRS Immobilization System by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological headrest.
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Cleared under the same submission
K182079 also covers:
- Solstat™ Immobilization System — Medtec LLC
- Solstat™ Immobilization System — Medtec LLC
- Solstice™ MR SRS Immobilization System — Medtec LLC
- Solstice™ MR SRS Immobilization System — Medtec LLC
- Solstice™ SRS Immobilization System — Medtec LLC
- Solstice™ Thermoplastic Frame — Medtec LLC
- Solstice™ Thermoplastic Frame — Medtec LLC
- Solstice™ Thermoplastic Frame — Medtec LLC
- Solstice™ Thermoplastic Frame — Medtec LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtec LLC
Sources (2)
- FDA UDI cfca9063-0fe6-4162-9f1f-aafd3df2c47f 37 fields · synced Jul 10, 2026
- EUDAMED 5fea77a0-2739-4c25-8a55-09173aac16b5 61 fields · synced Jul 10, 2026