Nova Microsonics Datavue Echo Analysis System
FDA 510(k) K897004 · Advanced Technology Laboratories, Inc.
510(k) numberK897004
Submission
- Device name
- Nova Microsonics Datavue Echo Analysis System
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- December 18, 1989
- Decision date
- March 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1435
- Specialty
- Cardiovascular
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More from Lidco, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K021966 | Q Lab SoftwareLLZ · Traditional | 07/02/2002SE |
| K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and…IYN · Traditional | 05/04/2001SE |
| K002144 | Medlink Diagnostic Offline WorkstationLLZ · Traditional | 09/28/2000SE |
| K992470 | Ultramark 400C/SONOACE 6000 Ultrasound SystemIYO · Traditional | 08/23/1999SE |
| K991671 | Hdi 5000 Diagnostic Ultrasound SystemIYO · Traditional | 06/18/1999SE |
| K961459 | Level 10 HdiIYO · Traditional | 03/26/1997SE |
| K935009 | PegasusIYN · Traditional | 10/11/1994SE |
| K940423 | Nova Microsonics Access Image Management Network/Access Acquisition ModuleLMD · Traditional | 07/29/1994SE |
| K905248 | Nova Microsonics Capricorn Digital Image SystemsDQK · Traditional | 02/28/1991SE |
| K903603 | Ultramark 9 Ultrasound System (Um 9)IYO · Traditional | 02/26/1991SE |
Questions and answers
When was Nova Microsonics Datavue Echo Analysis System cleared by the FDA?
Nova Microsonics Datavue Echo Analysis System (K897004) received a 510(k) decision of Substantially Equivalent on March 13, 1990, 85 days after the submission was received.
What is the product code of K897004?
The FDA product code is DXG – Computer, Diagnostic, Pre-Programmed, Single-Function, a Class II (moderate risk) device regulated under 21 CFR 870.1435.