.decimal Proton Aperture
510(k) K132236
.decimal Proton Aperture is a Class II device made by Decimal, Inc., cleared under FDA 510(k) K132236 on 16 Oct 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132236 | Date16 Oct 2013 | StatusActive |
Official records
- FDA 510(k) database K132236
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IXI
- FDA applicant
- .Decimal, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5710
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K132236
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| .decimal Proton Aperture 2.3 | 2.3 | 00851147007007 | On the market | |
| .decimal Proton Shell and Lid Assembly 2.3 | 2.3 | 00851147007083 | On the market |
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