The following data is part of a premarket notification filed by Tomtec Imaging Systems, Gmbh with the FDA for Panoramic Scan, Panoramic View, Widas, Wide Area Scanning.
| Device ID | K003936 |
| 510k Number | K003936 |
| Device Name: | PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Contact | Florian Eisenberger |
| Correspondent | Florian Eisenberger TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 Unterschleissheim, DE D-85716 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-20 |
| Decision Date | 2001-02-14 |