Identity
- Trade Name
- Panther OIS FDA UDI
- Generic Name
- Radiation therapy treatment record/verify system FDA UDI
- Device Name
- Panther OIS 3.1 FDA UDI
- Model / Reference
- 3.1 FDA UDI
- Description
- Panther OIS 3.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859032007224 FDA UDI
- 510(k) Number
- K211760 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy treatment record/verify 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
No
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 treatment record/verify system
Panther OIS by Prowess, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiation therapy treatment record/verify system.
- Varian Verification System (VVS) — VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED · Class II
- ARIA Radiation Therapy Management — Varian Medical Systems Imaging Laboratory GmbH · Class II
- Varian Verification Console — VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED · Class II
- Varian Verification Console — VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED · Class II
- ARIA Oncology Information System - Radiation Oncology — Varian Medical Systems, Inc · Class II
- ARIA Radiation Therapy Management Software — Varian Medical Systems, Inc · Class II
- Verification Console — VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED · Class II
- ARIA Radiation Therapy Management Software — Varian Medical Systems, Inc · Class II
Cleared under the same submission
K211760 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prowess, Inc.
Sources (1)
- FDA UDI 9d2bb47e-ecf8-4dec-ac6a-9d36adf0ad32 34 fields · synced May 31, 2026