Aloka Prosound Alpha 6 Diagnostic Ultrasound System
FDA 510(k) K093488 · Aloka Co., Ltd.
510(k) numberK093488
Submission
- Device name
- Aloka Prosound Alpha 6 Diagnostic Ultrasound System
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- November 10, 2009
- Decision date
- November 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K072285 | Aloka Ssd-Alpha 7 Ultrasound SystemITX · Traditional | 08/30/2007SE |
| K060059 | Aloka SD-3500 Ultrasound SystemIYN · Traditional | 01/13/2006SE |
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| K040719 | Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryIYO · Traditional | 03/26/2004SE |
| K033311 | Aloka SSD-5000 V5.0 Ultrasound SystemIYN · Traditional | 10/29/2003SE |
Questions and answers
When was Aloka Prosound Alpha 6 Diagnostic Ultrasound System cleared by the FDA?
Aloka Prosound Alpha 6 Diagnostic Ultrasound System (K093488) received a 510(k) decision of Substantially Equivalent on November 20, 2009, 10 days after the submission was received.
What is the product code of K093488?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.