CYPRESS ULTRASOUND SYSTEM
FDA 510(k) clearance K021497 · decided 2002-07-09
Clearance details
- K-number
- K021497
- Device name
- CYPRESS ULTRASOUND SYSTEM
- Applicant
- Acuson Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-09
- Decision date
- 2002-07-09
- Days to decision
- 61 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Acuson Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Acuson Cypress Echocardiography System recall (Z-0744-04) | Siemans Medial Solutions USA, Inc | 2004-07-20 |
| Acuson Cypress Echocardiography System. Imaging System recall (Z-0975-03) | Siemans Medial Solutions USA, Inc | 2003-07-02 |