Identity
- Trade Name
- PIM Portable Hand Palm Scanner FDA UDI
- Generic Name
- Radiation therapy treatment record/verify system FDA UDI
- Device Name
- The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified. FDA UDI
- Model / Reference
- C01-09-03 FDA UDI
- Description
- The Patient Identification Module (PIM) is used in radiation therapy clinics to verify the patient's identity prior to treatment by means of a portable sensor, in order to prevent patient mix-ups. An interlock disables the LINAC and treatment will not start so long as the patient is not successfully identified. FDA UDI
Identifiers
- Catalog Number
- C01-09-03 FDA UDI
- Primary DI / UDI-DI
- 08717953004055 FDA UDI
- 510(k) Number
- K960510 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiation therapy treatment record/verify system
PIM Portable Hand Palm Scanner by Cablon Medical B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiation therapy treatment record/verify system.
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- Varian Verification Console — VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED · Class II
- Varian Verification Console — VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED · Class II
- Panther OIS — Prowess, Inc. · 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
Cleared under the same submission
K960510 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 |
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Manufacturer
- Manufacturer
- Cablon Medical B.V.
Sources (1)
- FDA UDI 231863b8-d7fe-475a-9e33-76a8a37f7278 37 fields · synced May 30, 2026