The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Fuji Cr Imaging Plate.
| Device ID | K862414 |
| 510k Number | K862414 |
| Device Name: | FUJI CR IMAGING PLATE |
| Classification | Screen, Intensifying, Radiographic |
| 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 | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-25 |
| Decision Date | 1987-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410222101 | K862414 | 000 |
| 14547410059271 | K862414 | 000 |
| 14547410059288 | K862414 | 000 |
| 14547410059295 | K862414 | 000 |
| 14547410059301 | K862414 | 000 |
| 14547410059318 | K862414 | 000 |
| 14547410059325 | K862414 | 000 |
| 14547410059332 | K862414 | 000 |
| 14547410059349 | K862414 | 000 |
| 14547410059356 | K862414 | 000 |
| 14547410059424 | K862414 | 000 |
| 14547410059431 | K862414 | 000 |
| 14547410149453 | K862414 | 000 |
| 14547410177111 | K862414 | 000 |
| 14547410177128 | K862414 | 000 |
| 14547410059011 | K862414 | 000 |