Cardioscan - TM Being Applied for
FDA 510(k) K841263 · Interspec, Inc.
510(k) numberK841263
Submission
- Device name
- Cardioscan - TM Being Applied for
- Applicant
- Interspec, Inc.
Conshohocken, PA, US - Received
- March 26, 1984
- Decision date
- October 19, 1984
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K940671 | Interspec Apogee RX400 Ultrasound Imaging System and Doppler Ultrasound FlowmeterITX · Traditional | 11/22/1994SE |
| K924231 | Interspec Apogee ClaIYO · Traditional | 06/14/1993SE |
| K915696 | Interspec Apogee Endo-V Probe and Needle GuideITX · Traditional | 11/24/1992SE |
| K920678 | Ultrasound Imagaing System and Doppler FlowmeterITX · Traditional | 04/02/1992SE |
| K911073 | Probe Refill KitITX · Traditional | 06/06/1991SE |
| K910049 | Interspec Apogee, ModificationDPW · Traditional | 04/29/1991SE |
| K903839 | Interspec ApogeeDXK · Traditional | 11/16/1990SE |
| K900155 | Interspec 2 MHZ, Transcranial Pulsed Wave DopplerITX · Traditional | 10/05/1990SE |
| K892944 | Interspec Transesophageal Probe Model 4515JOP · Traditional | 07/19/1989SE |
| K890173 | Interspec ApogeeIYO · Traditional | 04/14/1989SE |
Questions and answers
When was Cardioscan - TM Being Applied for cleared by the FDA?
Cardioscan - TM Being Applied for (K841263) received a 510(k) decision of Substantially Equivalent on October 19, 1984, 207 days after the submission was received.
What is the product code of K841263?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.