HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
FDA 510(k) clearance K071992 · decided 2007-08-15
Clearance details
- K-number
- K071992
- Device name
- HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
- Applicant
- Varian Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2007-07-20
- Decision date
- 2007-08-15
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: recall (Z-1090-2012) | Varian Medical Systems, Inc. Oncology Systems | 2012-02-23 |
| Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04 recall (Z-1091-2012) | Varian Medical Systems, Inc. Oncology Systems | 2012-02-23 |
| High-Definition 120 Multileaf Collimator HD 120 MLC is an accessory x-ray collimator desig recall (Z-3052-2011) | Varian Medical Systems, Inc. Oncology Systems | 2011-08-22 |
| High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy syste recall (Z-1459-2008) | Varian Medical Systems Oncology Systems | 2008-08-02 |