FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Xario 200, V3.0
K Number: K143027
·
Decision Nov 20, 2014
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
1117
Applicant Total
58
Review Days
30
Basic Information
- Device Name
- Xario 200, V3.0
- K Number
- K143027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TOSHIBA MEDICAL SYSTEMS CORPORATION
- Date Received
- October 21, 2014
- Decision Date
- November 20, 2014
- 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.
Sonosite LX Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Vivid Pioneer
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
FDA 510(k)
FDA Class 2
·Radiology
TE Air Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Voluson Performance 16; Voluson Performance 18
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by TOSHIBA MEDICAL SYSTEMS CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | May 30, 2017 | Substantially Equivalent |
| K162183 | Vantage Galan 3T, MRT-3020, V4.0 | Nov 25, 2016 | Substantially Equivalent |
| K162155 | Xario 200 Diagnostic Ultrasound System V5.0 | Nov 1, 2016 | Substantially Equivalent |
| K162614 | Infinix, INFX-8000V, V6.35 | Oct 17, 2016 | Substantially Equivalent |
| K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Sep 21, 2016 | Substantially Equivalent |
| K160632 | Vantage Titan 1.5T, MRT-1510, V3.6 Software | Aug 23, 2016 | Substantially Equivalent |
| K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 | Jul 22, 2016 | Substantially Equivalent |
| K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 | Apr 1, 2016 | Substantially Equivalent |
| K152697 | INFX-8000C, V6.20 | Jan 15, 2016 | Substantially Equivalent |
| K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) | Nov 27, 2015 | Substantially Equivalent |