Identity
- Trade Name
- Raypilot Viewcath FDA UDI
- Generic Name
- Radiation therapy lesion localization urethral catheter, planning FDA UDI
- Device Name
- Raypilot Viewcath is a Foley catheter (a sterile single-use) for treatment planning prior to radiation therapy for men with prostate cancer. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Raypilot Viewcath is a Foley catheter (a sterile single-use) for treatment planning prior to radiation therapy for men with prostate cancer. FDA UDI
Identifiers
- Catalog Number
- 1005 FDA UDI
- Primary DI / UDI-DI
- 07350007951052 FDA UDI
- 510(k) Number
- K203722 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy lesion localization urethral catheter, planning 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy lesion localization urethral catheter, planning
Raypilot Viewcath by Micropos Medical AB (Publ) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy lesion localization urethral catheter, planning.
- Alatus — ANGIODYNAMICS, INC · Class II
Cleared under the same submission
K203722 also covers:
- Raypilot Extension Plate — Micropos Medical AB (Publ)
- 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)
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 380efe5a-d300-4592-943f-04f0fe485395 37 fields · synced May 30, 2026