Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1200PRO
FDA 510(k) K071289 · Shimadzu Medical Systems
510(k) numberK071289
Submission
- Device name
- Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1200PRO
- Applicant
- Shimadzu Medical Systems
Torrance, CA, US - Received
- May 8, 2007
- Decision date
- January 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
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| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K082224 | Diagnostic Ultrasound System Sarano, Echo View, ShimasonicITX · Traditional | 12/15/2008SE |
| K071291 | Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1100ITX · Traditional | 01/09/2008SE |
| K071287 | Echoview / Shimasonic Diagnostic Ultrasound Device, Model SDU-2200PROITX · Traditional | 01/09/2008SE |
| K061643 | Echo View/Shimasonic Diagnostic Ultrasound System, Model SDU-1200PROIYN · Traditional | 07/27/2006SE |
| K061637 | Echoview/ Shimasonic Diagnostic Ultrasound System, Model SDU-2200PROIYN · Traditional | 07/25/2006SE |
| K061641 | Echo View/Shimasonic Diagnostic Ultrasound System, Model SaranoIYO · Traditional | 07/14/2006SE |
| K052500 | DAR-8000FIZI · Abbreviated | 10/17/2005SE |
| K052076 | DAR-8000IIZI · Abbreviated | 09/02/2005SE |
| K050510 | Echoview/Shimasonic Diagnostic Ultrasound System, Model SDU-1100IYN · Traditional | 04/01/2005SE |
| K003515 | Echo View/Shimasonic Diagnostic Ultrasound System, Model SDU-1200IYN · Traditional | 02/12/2001SE |
Questions and answers
When was Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1200PRO cleared by the FDA?
Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1200PRO (K071289) received a 510(k) decision of Substantially Equivalent on January 9, 2008, 246 days after the submission was received.
What is the product code of K071289?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.