Ultrasound Data Analysis System, Model DAS-RS1
FDA 510(k) K081843 · Aloka Co., Ltd.
510(k) numberK081843
Submission
- Device name
- Ultrasound Data Analysis System, Model DAS-RS1
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- June 30, 2008
- Decision date
- July 15, 2008
- 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 |
| K043196 | Aloka Ssd-Alpha 10 Ultrasound SystemIYN · Traditional | 11/30/2004SE |
| K040719 | Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryIYO · Traditional | 03/26/2004SE |
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Questions and answers
When was Ultrasound Data Analysis System, Model DAS-RS1 cleared by the FDA?
Ultrasound Data Analysis System, Model DAS-RS1 (K081843) received a 510(k) decision of Substantially Equivalent on July 15, 2008, 15 days after the submission was received.
What is the product code of K081843?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.