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Solstat™ Immobilization System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CHS06Model Stereotactic Radiosurgery and Stereotactic Radiotherapy Devices
by Medtec LLC
Identity
- Trade Name
- Solstat™ 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
- CHS06 EUDAMEDFDA UDIStereotactic Radiosurgery and Stereotactic Radiotherapy Devices EUDAMED
- Description
- Head support system for use with Type-S™ systems FDA UDI
Identifiers
- Catalog Number
- CHS06 FDA UDI
- Primary DI / UDI-DI
- 00841439112519 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 12.61 Inch FDA UDIWidth — 10.35 Inch FDA UDI
Category: Radiological headrest
Solstat™ Immobilization System by Medtec LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological headrest.
- Neck & Brachial Plexus SatPad™ Set — Sat Pad Inc. · Class II
- Nurofit Premiere™ — Qfix · Class I
- Neuro Head Holder — Qfix · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class I
- SCANCOAT — DOMICO MED-DEVICE, LLC · Class II
- DSA-3Q Head Holder — Qfix · Class I
- DSA-2T Head Holder — Qfix · Class I
- pearltec — Pearl Technology AG · Class I
Cleared under the same submission
K182079 also covers:
- 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™ 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
European Union Unknown
MDR
United States Pending data
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 8603ebb0-b676-4a20-8788-2e1bb7d6ddb7 37 fields · synced Jul 24, 2026
- EUDAMED 396eeb38-4e8a-48c7-9657-82b0b8d41fa6 61 fields · synced Jul 24, 2026