Clearscan
by Esi, Inc.
510(k) K080119
Clearscan is a medical device (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Esi, Inc., cleared under FDA 510(k) K080119 on 21 Feb 2008, 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 | NumberK080119 | Date21 Feb 2008 | StatusActive |
Official records
- FDA 510(k) database K080119
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- Withdrawn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
Devices cleared under K080119
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 | |||
|---|---|---|---|---|
| ClearScan® CS200 | CS200 / CS200 | B360CS2000 | — | On the market |
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