.decimal Photon Block
510(k) K123015
.decimal Photon Block is a Class II device made by Decimal, Inc., cleared under FDA 510(k) K123015 on 21 Nov 2012, 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 | NumberK123015 | Date21 Nov 2012 | StatusActive |
Official records
- FDA 510(k) database K123015
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- Withdrawn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 K123015
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 Photon Block 1.3 | 1.3 | 00851147007045 | — | On the market |
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