SMART FINDER
System, X-ray, Mammographic
IMS Giotto S.p.A.
The following data is part of a premarket notification filed by Ims Giotto S.p.a. with the FDA for Smart Finder.
Pre-market Notification Details
| Device ID | K203509 |
| 510k Number | K203509 |
| Device Name: | SMART FINDER |
| Classification | System, X-ray, Mammographic |
| Applicant | IMS Giotto S.p.A. VIA Sagittario, 5 Sasso Marconi, IT 40037 |
| Contact | Antonella Rossi |
| Correspondent | Marisa Testa Thema S.r.l. Via Saragat, 5 Imola, IT 40026 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-30 |
| Decision Date | 2021-07-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056977360113 | K203509 | 000 |
Trademark Results [SMART FINDER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMART FINDER 85372024 4317831 Dead/Cancelled |
Worthwhile Products 2011-07-14 |
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