The following data is part of a premarket notification filed by Aetmed, S.p.a. with the FDA for Aetmed Image Processing Software.
| Device ID | K012093 |
| 510k Number | K012093 |
| Device Name: | AETMED IMAGE PROCESSING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | AETMED, S.P.A. 7992 CASTLEWAY DR. Indianapolis, IN 46250 |
| Contact | Colleen Hittle |
| Correspondent | Colleen Hittle AETMED, S.P.A. 7992 CASTLEWAY DR. Indianapolis, IN 46250 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-05 |
| Decision Date | 2001-09-21 |
| Summary: | summary |