Aixplorer
by Supersonic Imagine 7 variants
510(k) K142100
Aixplorer is a Class II device made by Supersonic Imagine, cleared under FDA 510(k) K142100 on 20 Nov 2014, 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 | NumberK142100 | Date20 Nov 2014 | StatusActive |
Official records
- FDA 510(k) database K142100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYN
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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