The following data is part of a premarket notification filed by Tom Tec Imaging Systems Gmbh with the FDA for Image-com 5.0.
| Device ID | K122289 |
| 510k Number | K122289 |
| Device Name: | IMAGE-COM 5.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | TOM TEC IMAGING SYSTEMS GMBH EDISONSTR. 6 Unterschleissheim, DE 85716 |
| Contact | Bernhard Mumm |
| Correspondent | Bernhard Mumm TOM TEC IMAGING SYSTEMS GMBH EDISONSTR. 6 Unterschleissheim, DE 85716 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-10-24 |
| Summary: | summary |