K885327 is an FDA 510(k) clearance for the PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM. This device is classified as a Device, Digital Image Storage, Radiological (Class I - General Controls, product code LMB).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on May 11, 1989, 134 days after receiving the submission on December 28, 1988.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2010. Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images..
| 510(k) Number | K885327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1988 |
| Decision Date | May 11, 1989 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | LMB — Device, Digital Image Storage, Radiological |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.2010 |
| Definition | Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images. |