The following data is part of a premarket notification filed by Prism Imaging, Inc. with the FDA for Software Program Used W/prism Products.
| Device ID | K904978 |
| 510k Number | K904978 |
| Device Name: | SOFTWARE PROGRAM USED W/PRISM PRODUCTS |
| Classification | Echocardiograph |
| Applicant | PRISM IMAGING, INC. C/O HYMAN, PHELPS & MCNAMARA 1120 G STREET, N.W. Washington, DC 20005 |
| Contact | Robert A Dormer |
| Correspondent | Robert A Dormer PRISM IMAGING, INC. C/O HYMAN, PHELPS & MCNAMARA 1120 G STREET, N.W. Washington, DC 20005 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-01 |
| Decision Date | 1991-02-25 |