FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K Number: K110510
·
Decision May 16, 2011
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
22
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K Number
- K110510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonoscape Company Limited
- Date Received
- February 22, 2011
- Decision Date
- May 16, 2011
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYN), ordered by most recent decision date.
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ES-Series
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
LOGIQ e
FDA 510(k)
FDA Class 2
·Radiology
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 Sonoscape Company Limited
| K Number | Device Name | ||
|---|---|---|---|
| K150045 | S30/S40 Digital Color Doppler Ultraound System | Apr 28, 2015 | Substantially Equivalent |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Jan 29, 2015 | Substantially Equivalent |
| K142815 | S22 Digital Color Doppler Ultrasound System | Jan 28, 2015 | Substantially Equivalent |
| K142710 | S9 Portable Digital Color Doppler Ultrasound System | Jan 5, 2015 | Substantially Equivalent |
| K142474 | S12 Digital Color Doppler Ultrasound System | Dec 19, 2014 | Substantially Equivalent |
| K131262 | DIGITAL ELECTROCARDIOGRAPHS | Nov 14, 2013 | Substantially Equivalent |
| K132527 | DIGITAL COLOR DOPPLER ULTASOUND SYSTEM | Nov 14, 2013 | Substantially Equivalent |
| K132768 | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Oct 4, 2013 | Substantially Equivalent |
| K131213 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Jun 21, 2013 | Substantially Equivalent |
| K130801 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Jun 14, 2013 | Substantially Equivalent |