Mavis C
FDA 510(k) K813002 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK813002
Submission
- Device name
- Mavis C
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Mchenry, IL, US - Received
- October 26, 1981
- Decision date
- March 1, 1982
- 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
Other 510(k)s with product code DXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging CatheterDXK · Special | Boston Scientific Corporation | 05/17/2018SE |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac…DXK · Special | Boston Scientific Corporation | 02/26/2016SE |
| 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 |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K171850 | Philips CT Big BoreJAK · Traditional | 11/09/2017SE |
| K172406 | Ingenuity TFKPS · Traditional | 10/06/2017SE |
| K162838 | Philips iCT CT SystemJAK · Traditional | 04/07/2017SE |
| K163711 | IQon Spectral CTJAK · Traditional | 04/05/2017SE |
| K170086 | Pinnacle Radiation Therapy Planning SystemMUJ · Special | 02/09/2017SE |
| K160743 | Philips Ingenuity CTJAK · Traditional | 08/08/2016SE |
| K153444 | Philips Multislice CT System with Low Dose CT Lung CancerJAK · Traditional | 04/08/2016SE |
| K130992 | PINNACLE3 Radiation Therapy Planning SystemIYE · Traditional | 06/14/2013SE |
| K111336 | Ebw NM 2.0LLZ · Traditional | 05/24/2011SE |
| K111024 | Jetpack 2.0LLZ · Traditional | 04/21/2011SE |
Questions and answers
When was Mavis C cleared by the FDA?
Mavis C (K813002) received a 510(k) decision of Substantially Equivalent on March 1, 1982, 126 days after the submission was received.
What is the product code of K813002?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.