The following data is part of a premarket notification filed by Inficon Leybold-heraeus, Inc. with the FDA for Fc-1000 Fluoroscopic Imaging Computer.
| Device ID | K854810 |
| 510k Number | K854810 |
| Device Name: | FC-1000 FLUOROSCOPIC IMAGING COMPUTER |
| Classification | System, Image Processing, Radiological |
| Applicant | INFICON LEYBOLD-HERAEUS, INC. 6500 FLY RD. East Syracuse, NY 13057 |
| Contact | John G Stratakos |
| Correspondent | John G Stratakos INFICON LEYBOLD-HERAEUS, INC. 6500 FLY RD. East Syracuse, NY 13057 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-03 |
| Decision Date | 1986-04-15 |