SureWave Elastography (Q7000225)
by Quality Electrodynamics LLC
510(k) K242006
SureWave Elastography (Q7000225) is a Class II device made by Quality Electrodynamics LLC, cleared under FDA 510(k) K242006 on 12 Feb 2025, 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 | NumberK242006 | Date12 Feb 2025 | StatusActive |
Official records
- FDA 510(k) database K242006
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNH
- FDA applicant
- Quality Electrodynamics, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K242006
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 | |||
|---|---|---|---|---|
| SureWave Elastography Q7000225 | Q7000225 | 00814848020775 | — | On the market |
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