The following data is part of a premarket notification filed by Agfa Healthcare Corporation with the FDA for Orthogon.
| Device ID | K073271 |
| 510k Number | K073271 |
| Device Name: | ORTHOGON |
| Classification | System, Image Processing, Radiological |
| Applicant | AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Tom Holbrook |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2007-12-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOGON 86620410 4884864 Live/Registered |
ORTHOGON GROUP, LLC 2015-05-05 |
![]() ORTHOGON 86120363 not registered Dead/Abandoned |
Cambium Networks, Ltd. 2013-11-15 |
![]() ORTHOGON 79278781 not registered Live/Pending |
Harris Orthogon GmbH 2019-10-01 |
![]() ORTHOGON 76531655 2991036 Dead/Cancelled |
CAMBIUM (US), L.L.C. 2003-07-23 |
![]() ORTHOGON 72308269 0873413 Dead/Expired |
BAUSCH & LOMB INCORPORATED 1968-09-26 |