SSD-1000 Diagnostic Ultrasound System
FDA 510(k) K012253 · Aloka Co., Ltd.
510(k) numberK012253
Submission
- Device name
- SSD-1000 Diagnostic Ultrasound System
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- July 18, 2001
- Decision date
- August 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K111227 | Aloka SSD-3500 Diagnostic Ultrasound SystemIYN · Traditional | 05/13/2011SE |
| K110207 | Aloka Prousound F75 Diagnostic Ultrasound SystemIYN · Traditional | 02/17/2011SE |
| K093488 | Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemIYO · Traditional | 11/20/2009SE |
| K083254 | Aloka Prousound 2 Diagnostic Ultrasound SystemIYN · Traditional | 12/19/2008SE |
| K081843 | Ultrasound Data Analysis System, Model DAS-RS1LLZ · Traditional | 07/15/2008SE |
| K080176 | Aloka Prosound 6 Diagnostic Ultrasound SystemIYN · Traditional | 02/29/2008SE |
| 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 |
Questions and answers
When was SSD-1000 Diagnostic Ultrasound System cleared by the FDA?
SSD-1000 Diagnostic Ultrasound System (K012253) received a 510(k) decision of Substantially Equivalent on August 30, 2001, 43 days after the submission was received.
What is the product code of K012253?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.