The following data is part of a premarket notification filed by Giotto Usa, Llc with the FDA for Biopsy Digit-am.
| Device ID | K062039 |
| 510k Number | K062039 |
| Device Name: | BIOPSY DIGIT-AM |
| Classification | System, X-ray, Mammographic |
| Applicant | GIOTTO USA, LLC 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Contact | Allison Scott |
| Correspondent | Allison Scott GIOTTO USA, LLC 11460 N MERIDIAN ST., STE 150 Carmel, IN 46032 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-09-11 |
| Summary: | summary |