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Encompass™
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref RT-4600-20Model Head and Neck
by Qfix
Identity
- Trade Name
- Encompass™ FDA UDI
- Generic Name
- Head/neck procedure positioner FDA UDI
- Device Name
- SRS Cushion Support FDA UDI
- Model / Reference
- RT-4600-20 EUDAMEDFDA UDIHead and Neck EUDAMED
- Description
- SRS Cushion Support FDA UDI
Identifiers
- Catalog Number
- RT-4600-20 FDA UDI
- Primary DI / UDI-DI
- 00841962119719 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621HEADNECKX4 EUDAMED
- 510(k) Number
- K152321 FDA UDI
- FDA Product Code
- IYE FDA UDIJAI FDA UDIJAK FDA UDIKPS FDA UDILHN FDA UDILNH FDA UDIOUO FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Head/neck procedure positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI892.5770 FDA UDI892.1750 FDA UDI892.1200 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Head/neck procedure positioner
Encompass™ by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Head/neck procedure positioner.
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- ASSY, SCAN BOARD, HILL-ROM PROGRESSA — Neurologica Corporation · Class II
- Orfit Industries — Orfit Industries NV · Class II
- OPTION, EXTENDED SCANBOARD LONG POST WITH TARGET — Neurologica Corporation · Class II
- Orfit Industries — Orfit Industries NV · Class II
- AADCO — AADCO MEDICAL, INC. · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- Orfit Industries — Orfit Industries NV · Class II
Cleared under the same submission
K152321 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 4d842744-20b3-4b15-a411-2e1cc1862b32 36 fields · synced Jun 18, 2026
- EUDAMED 7ea94f6e-b1ca-4913-83b4-31a3e4912b10 61 fields · synced Jun 18, 2026