.decimal Aperture
510(k) K071077
.decimal Aperture is a Class II device made by Decimal, Inc., cleared under FDA 510(k) K071077 on 18 May 2007, 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 | NumberK071077 | Date18 May 2007 | StatusActive |
Official records
- FDA 510(k) database K071077
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- Withdrawn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
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