Echo View/Shimasonic Diagnostic Ultrasound System
510(k) K970508
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970508 | Date4 Aug 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Echo View/Shimasonic Diagnostic Ultrasound System is a diagnostic ultrasound system. It is classified as a System, Imaging, Pulsed Doppler, Ultrasonic. The device is used in radiology.
The system is supplied as a Class II device and has been issued FDA 510(k) clearances. It is available in models such as SDU-2200 and SDU-1200PRO. The device is intended for use in medical imaging and is manufactured by Shimadzu Medical Systems.
Other devices from Shimadzu Medical Systems
Questions
AI-generated answers, 6 Oct 2026
What is the Echo View/Shimasonic Diagnostic Ultrasound System used for?
The Echo View/Shimasonic Diagnostic Ultrasound System is used in radiology for medical imaging, providing diagnostic ultrasound capabilities.
What models are available for the Echo View/Shimasonic Diagnostic Ultrasound System?
The system is available in models such as SDU-2200 and SDU-1200PRO, offering varying features and capabilities.
Is the Echo View/Shimasonic Diagnostic Ultrasound System cleared by the FDA?
Yes, the Echo View/Shimasonic Diagnostic Ultrasound System has been issued FDA 510(k) clearances, indicating it is substantially equivalent to a predicate device.