Aixplorer
by Supersonic Imagine 7 variants
510(k) K102041
Aixplorer is a Class II device made by Supersonic Imagine, cleared under FDA 510(k) K102041 on 13 Oct 2010, 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 | NumberK102041 | Date13 Oct 2010 | StatusActive |
Official records
- FDA 510(k) database K102041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITX
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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