SOFTWARE PROGRAM USED W/PRISM PRODUCTS
FDA 510(k) clearance K904978 · decided 1991-02-25
Clearance details
- K-number
- K904978
- Device name
- SOFTWARE PROGRAM USED W/PRISM PRODUCTS
- Applicant
- Prism Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-01
- Decision date
- 1991-02-25
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- DXK
- Device class
- 2
- Regulation number
- 870.2330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042) | Boston Scientific Corporation | 2018-05-17 |
| Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) (K160173) | Boston Scientific Corporation | 2016-02-26 |
| IN-VISION IMAGING SYSTEM (K031148) | Jomed, Inc. | 2003-05-28 |
| 9750 ATHENA ETHERNET OPTION (K934887) | S & W Medico Teknik A/S | 1994-01-14 |
| ACCESSORY TO GENESIS III (GCFM) (K913209) | Biosound, Inc. | 1992-05-15 |
| CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (K911384) | Endosonics Corp. | 1991-06-25 |
| MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832) | Hewlett-Packard Co. | 1991-04-22 |
| VISTA VIEWING STATION (K904975) | Prism Imaging, Inc. | 1991-02-25 |
| CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976) | Prism Imaging, Inc. | 1991-02-25 |
| CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977) | Prism Imaging, Inc. | 1991-02-25 |
| PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (K910029) | Spacelabs, Inc. | 1991-01-31 |
| INTERSPEC APOGEE (K903839) | Interspec, Inc. | 1990-11-16 |
Recalls involving this device
No recalls on record reference this clearance.