The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Digital Cardiac Imaging (dci) System.
| Device ID | K885327 |
| 510k Number | K885327 |
| Device Name: | PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | Robert T Jossick |
| Correspondent | Robert T Jossick PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-05-11 |