FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Terason uSmart3200T Ultrasound System
K Number: K150533
·
Decision May 9, 2015
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
17
Review Days
68
Basic Information
- Device Name
- Terason uSmart3200T Ultrasound System
- K Number
- K150533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TERATECH CORP.
- Date Received
- March 2, 2015
- Decision Date
- May 9, 2015
- 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 TERATECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K150148 | Terason uSmart3300 Ultrasound System | Feb 20, 2015 | Substantially Equivalent |
| K140773 | TERASON USMART3300 ULTRASOUND SYSTEM | May 30, 2014 | Substantially Equivalent |
| K140834 | TERASON USMART3400 ULTRASOUND SYSTEM | Apr 25, 2014 | Substantially Equivalent |
| K140524 | TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM | Mar 21, 2014 | Substantially Equivalent |
| K131209 | TERASON USMART3200T ULTRASOUND SYSTEM | May 24, 2013 | Substantially Equivalent |
| K112953 | TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS | Feb 3, 2012 | Substantially Equivalent |
| K110482 | PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS | Mar 18, 2011 | Substantially Equivalent |
| K110020 | TERASON T3200 ULTRASOUND SYSTEM | Jan 20, 2011 | Substantially Equivalent |
| K080234 | TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO | Feb 14, 2008 | Substantially Equivalent |
| K051334 | TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER | Jun 3, 2005 | Substantially Equivalent |