Eub 151 Ultrasound System/Eub 150 Ultrasound
FDA 510(k) K862859 · Biosound, Inc.
510(k) numberK862859
Submission
- Device name
- Eub 151 Ultrasound System/Eub 150 Ultrasound
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- July 29, 1986
- Decision date
- February 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
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| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904977 | Cine/View Plus - Cardiology WorkstationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971700 | Biopsy Accessory for Ultrasound TransducerITX · Traditional | 07/09/1997SE |
| K963936 | Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional | 03/31/1997SE |
| K963262 | Artoscan MLNH · Traditional | 03/28/1997SE |
| K963662 | Galileo Evoked PotentialreGWF · Traditional | 02/26/1997SE |
| K953716 | Intracavity TransducersITX · Traditional | 04/17/1996SE |
| K953530 | Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-AIYO · Traditional | 04/08/1996SE |
| K953819 | Diagnostic Ultrasound TranducerITX · Traditional | 03/01/1996SE |
| K953759 | Diagnostic Ultrasound TransducerITX · Traditional | 03/01/1996SE |
| K955458 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 02/12/1996SE |
| K953579 | Tee ProbeITX · Traditional | 02/02/1996SE |
Questions and answers
When was Eub 151 Ultrasound System/Eub 150 Ultrasound cleared by the FDA?
Eub 151 Ultrasound System/Eub 150 Ultrasound (K862859) received a 510(k) decision of Substantially Equivalent on February 2, 1987, 188 days after the submission was received.
What is the product code of K862859?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.