MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
FDA 510(k) clearance K091403 · decided 2009-07-29
Clearance details
- K-number
- K091403
- Device name
- MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
- Applicant
- Oncology Tech, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-05-12
- Decision date
- 2009-07-29
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- IXI
- Device class
- 2
- Regulation number
- 892.5710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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| .DECIMAL PHOTON BLOCK (K123015) | .Decimal, Inc. | 2012-11-21 |
| APEX (K111676) | Elekta Limited | 2011-09-30 |
| .DECIMAL ELECTRON APERTURE (K111759) | .Decimal, Inc. | 2011-09-09 |
| BOLUS COMPENSATOR (K091911) | .Decimal, Inc. | 2009-07-21 |
| AXXENT FLEXISHIELD MINI (K090417) | Xoft, Inc. | 2009-06-23 |
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Recalls involving this device
No recalls on record reference this clearance.