Identity
- Trade Name
- 80 Leaf Assy, MLC Head FDA UDI
- Generic Name
- Automatic-aperture-control accelerator system collimator FDA UDI
- Model / Reference
- 8.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899475002325 FDA UDI
- 510(k) Number
- K181404 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Automatic-aperture-control accelerator system collimator 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-aperture-control accelerator system collimator
80 Leaf Assy, MLC Head by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-aperture-control accelerator system collimator.
- Integrity™ — Elekta Inc. · Class II
- Apex™ — Elekta Inc. · Class II
- Agility™ — Elekta Inc. · Class II
- Millennium 120-leaf Multileaf Collimator — Varian Medical Systems, Inc · Class II
- HD 120 MLC Head Assembly — Varian Medical Systems, Inc · Class II
- 120 Leaf Assy, MLC Head — Varian Medical Systems, Inc · Class II
- High-Definition 120 Multileaf Collimator — Varian Medical Systems, Inc · Class II
- Millennium 80-leaf Multileaf Collimator — Varian Medical Systems, Inc · Class II
Cleared under the same submission
K181404 also covers:
- 120 Leaf Assy, MLC Head — Varian Medical Systems, Inc
- Clinac iX — Varian Medical Systems, Inc
- HD 120 MLC Head Assembly — Varian Medical Systems, Inc
- Novalis TX — Varian Medical Systems, Inc
- Trilogy — Varian Medical Systems, Inc
- Trilogy TX Image-Guided Radiosurgery — Varian Medical Systems, Inc
- Varian Collimator Accessories 20 cm wedge set lower — Varian Medical Systems, Inc
- Varian Collimator Accessories 30 CM wedge set lower (JITKIT) — Varian Medical Systems, Inc
- Varian Collimator Accessories 30 CM wedge set upper (JITKIT) — Varian Medical Systems, Inc
- Varian Collimator Accessories 30 cm compensator assembly — Varian Medical Systems, Inc
- Varian Collimator Accessories Lead wedge set lower (JITKIT) — Varian Medical Systems, Inc
- Varian Collimator Accessories Lead wedge set upper (JITKIT) — Varian Medical Systems, Inc
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
- Varian Medical Systems, Inc
Sources (1)
- FDA UDI 71562918-9613-4141-a573-6130de1452e4 33 fields · synced Jun 1, 2026