The following data is part of a premarket notification filed by Advanced Image Enhancement with the FDA for Aie Region Of Interest Image Enhancement.
| Device ID | K062059 |
| 510k Number | K062059 |
| Device Name: | AIE REGION OF INTEREST IMAGE ENHANCEMENT |
| Classification | System, Image Processing, Radiological |
| Applicant | ADVANCED IMAGE ENHANCEMENT 25 WALNUT STREET Monroe, CT 06468 |
| Contact | Jillian M Reed |
| Correspondent | Jillian M Reed ADVANCED IMAGE ENHANCEMENT 25 WALNUT STREET Monroe, CT 06468 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-20 |
| Decision Date | 2006-09-06 |
| Summary: | summary |