The following data is part of a premarket notification filed by Medx, Inc. with the FDA for Giotto Image.
| Device ID | K012953 |
| 510k Number | K012953 |
| Device Name: | GIOTTO IMAGE |
| Classification | System, X-ray, Mammographic |
| Applicant | MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Contact | Floyd R Rowan |
| Correspondent | Floyd R Rowan MEDX, INC. 3456 NORTH RIDGE AVE., #100 Arlington Heights, IL 60004 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18056977360080 | K012953 | 000 |