Genesis II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM an
FDA 510(k) K873032 · Biosound, Inc.
510(k) numberK873032
Submission
- Device name
- Genesis II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM an
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- August 4, 1987
- Decision date
- February 18, 1988
- 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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| K031148 | In-Vision Imaging SystemDXK · Special | Jomed, Inc. | 05/28/2003SE |
| K934887 | 9750 Athena Ethernet OptionDXK · Traditional | S & W Medico Teknik A/S | 01/14/1994SE |
| K913209 | Accessory to Genesis III (GCFM)DXK · Traditional | Biosound, Inc. | 05/15/1992SE |
| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
| K904832 | Modified Syst: Sonos 500/1000 Ultrsound Imag SystDXK · Traditional | Hewlett-Packard Co. | 04/22/1991SE |
| 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 |
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|---|---|---|
| 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 Genesis II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM an cleared by the FDA?
Genesis II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM an (K873032) received a 510(k) decision of Substantially Equivalent on February 18, 1988, 198 days after the submission was received.
What is the product code of K873032?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.