The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Philips Computed Radiography System (pcr).
| Device ID | K864519 |
| 510k Number | K864519 |
| Device Name: | PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) |
| Classification | System, Image Processing, Radiological |
| Applicant | PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Contact | Sayigh, Phd |
| Correspondent | Sayigh, Phd PAREXEL INTL. CORP. 55 WHEELER ST. Cambridge, MA 02138 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-17 |
| Decision Date | 1987-02-13 |