The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for Fti 100 Medical Thermal Imager.
| Device ID | K862416 |
| 510k Number | K862416 |
| Device Name: | FTI 100 MEDICAL THERMAL IMAGER |
| Classification | Camera, Multi Format, 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 | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-25 |
| Decision Date | 1986-07-01 |