Identity
- Trade Name
- Raypilot Extension Plate FDA UDI
- Generic Name
- Radiation therapy invasive marker lesion localization system FDA UDI
- Device Name
- Raypilot Extension Plate is aimed to create even surface for head and legs when the patient lies down on Raypilot receiver. One or several extension plates can be connected. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Raypilot Extension Plate is aimed to create even surface for head and legs when the patient lies down on Raypilot receiver. One or several extension plates can be connected. FDA UDI
Identifiers
- Catalog Number
- 2021 FDA UDI
- Primary DI / UDI-DI
- 07350007952219 FDA UDI
- 510(k) Number
- K203722 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy invasive marker lesion localization system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Radiation therapy invasive marker lesion localization system
Raypilot Extension Plate by Micropos Medical AB (Publ) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy invasive marker lesion localization system.
- Calypso Beacon Care Package-Lung — Varian Medical Systems, Inc · Class II
- Beacon Care Package - Soft Tissue (17G) — Varian Medical Systems, Inc · Class II
- Beacon Care Package - Soft Tissue (14G) — Varian Medical Systems, Inc · Class II
- Beacon Care Package - Prostate — Varian Medical Systems, Inc · Class II
- Calypso System — Varian Medical Systems, Inc · Class II
- Beacon Care Package - Soft Tissue (17G) — Varian Medical Systems, Inc · Class II
- Raypilot Table Displacement Meter — Micropos Medical AB (Publ) · Class II
- Raypilot Matching Network — Micropos Medical AB (Publ) · Class II
Cleared under the same submission
K203722 also covers:
- Raypilot Hypocath — Micropos Medical AB (Publ)
- Raypilot Matching Network — Micropos Medical AB (Publ)
- Raypilot Power Box — Micropos Medical AB (Publ)
- Raypilot Quality Control Kit — Micropos Medical AB (Publ)
- Raypilot Receiver — Micropos Medical AB (Publ)
- Raypilot Software — Micropos Medical AB (Publ)
- Raypilot System Cable — Micropos Medical AB (Publ)
- Raypilot Table Displacement Meter — Micropos Medical AB (Publ)
- Raypilot Transmitter Cable — Micropos Medical AB (Publ)
- Raypilot Transmitter Tester — Micropos Medical AB (Publ)
- Raypilot Viewcath — Micropos Medical AB (Publ)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micropos Medical AB (Publ)
Sources (1)
- FDA UDI f5f5ac9e-4ab4-4320-a9b7-f91a4b1c0051 38 fields · synced May 30, 2026