FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUS-7000 Digital Color Doppler Ultrasound System
K Number: K172055
·
Decision Aug 31, 2017
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
16
Review Days
56
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Basic Information
- Device Name
- DUS-7000 Digital Color Doppler Ultrasound System
- K Number
- K172055
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Instrumentations, Inc.
- Date Received
- July 6, 2017
- Decision Date
- August 31, 2017
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
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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SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Advanced Instrumentations, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | Dec 1, 2017 | Substantially Equivalent |
| K141194 | FM-3000 FETAL MONITOR | Nov 19, 2014 | Substantially Equivalent |
| K132077 | PATIENT MONITOR | Apr 23, 2014 | Substantially Equivalent |
| K132059 | DIAGNOSTIC ULTRASOUND SYSTEM | Oct 25, 2013 | Substantially Equivalent |
| K123048 | PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO | Jan 11, 2013 | Substantially Equivalent |
| K120075 | AM-6000 ANESTHESIA MACHINE | Jan 26, 2012 | Substantially Equivalent |
| K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR | Dec 21, 2011 | Substantially Equivalent |
| K112529 | TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER | Oct 27, 2011 | Substantially Equivalent |
| K111934 | PD-100 SERIES ULTRASONIC POCKET DOPPLER | Sep 22, 2011 | Substantially Equivalent |
| K112022 | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Sep 22, 2011 | Substantially Equivalent |