The following data is part of a premarket notification filed by Giotto Usa, Llc with the FDA for Giotto Image 3d, Giotto Image 3d-l.
| Device ID | K111434 |
| 510k Number | K111434 |
| Device Name: | GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GIOTTO USA, LLC 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Contact | Patrick Mooney |
| Correspondent | Patrick Mooney GIOTTO USA, LLC 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2011-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837190035 | K111434 | 000 |
| 18056977360073 | K111434 | 000 |
| 18056977360066 | K111434 | 000 |