.DECIMAL APERTURE
FDA 510(k) clearance K071077 · decided 2007-05-18
Clearance details
- K-number
- K071077
- Device name
- .DECIMAL APERTURE
- Applicant
- .Decimal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-17
- Decision date
- 2007-05-18
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- IXI
- Device class
- 2
- Regulation number
- 892.5710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sanford, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ricoh 3D for Healthcare Bolus (K253025) | Ricoh 3D For Healthcare, LLC | 2026-04-06 |
| VHA Radiotherapy Bolus (K222639) | Vha Dean | 2022-11-04 |
| VSP Bolus (K214093) | 3D Systems | 2022-03-30 |
| .DECIMAL PROTON APERTURE (K132236) | .Decimal, Inc. | 2013-10-16 |
| CURA COMPENSATOR (K131150) | Cura Medical Technologies, LLC | 2013-07-30 |
| CURA COLLIMATOR (K123893) | Cura Medical Technologies, LLC | 2013-03-04 |
| .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 |
| MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (K091403) | Oncology Tech, LLC | 2009-07-29 |
| BOLUS COMPENSATOR (K091911) | .Decimal, Inc. | 2009-07-21 |
| AXXENT FLEXISHIELD MINI (K090417) | Xoft, Inc. | 2009-06-23 |
Recalls involving this device
No recalls on record reference this clearance.