FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
K Number: K163635
·
Decision Jan 12, 2017
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
2
Review Days
21
Basic Information
- Device Name
- ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
- K Number
- K163635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Solutions USA, Inc. Ultrasound Group
- Date Received
- December 22, 2016
- Decision Date
- January 12, 2017
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Siemens Medical Solutions USA, Inc. Ultrasound Group
| K Number | Device Name | ||
|---|---|---|---|
| K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Feb 2, 2018 | Substantially Equivalent |