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 |