ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K063803 · decided 2007-01-05
Clearance details
- K-number
- K063803
- Device name
- ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Siemens Medical Solutions USA, Inc., Ultrasound DI
- Decision
- Substantially Equivalent
- Date received
- 2006-12-22
- Decision date
- 2007-01-05
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountain View, CA, US
- Third-party review
- Yes
- Expedited review
- No
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