FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
.DECIMAL PROTON APERTURE
K Number: K132236
·
Decision Oct 16, 2013
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
50
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- .DECIMAL PROTON APERTURE
- K Number
- K132236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5710
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- .Decimal, Inc.
- Date Received
- July 18, 2013
- Decision Date
- October 16, 2013
- Product Code
- IXI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by .Decimal, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150547 | .decimal Astroid Dosimetry App | May 15, 2015 | Substantially Equivalent |
| K123015 | .DECIMAL PHOTON BLOCK | Nov 21, 2012 | Substantially Equivalent |
| K111759 | .DECIMAL ELECTRON APERTURE | Sep 9, 2011 | Substantially Equivalent |
| K091911 | BOLUS COMPENSATOR | Jul 21, 2009 | Substantially Equivalent |
| K083672 | P.D SOFTWARE | Apr 13, 2009 | Substantially Equivalent |
| K071078 | .DECIMAL RANGE COMPENSATOR | May 22, 2007 | Substantially Equivalent |
| K071077 | .DECIMAL APERTURE | May 18, 2007 | Substantially Equivalent |
| K061440 | P.D | Jun 27, 2006 | Substantially Equivalent |