The following data is part of a premarket notification filed by General Electric Company with the FDA for Senograph Ds, Senograph Essenstial.
| Device ID | K103485 |
| 510k Number | K103485 |
| Device Name: | SENOGRAPH DS, SENOGRAPH ESSENSTIAL |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GENERAL ELECTRIC COMPANY 3000 N. GRANDVIEW BLVD., W-709 Waukesha, WI 53188 |
| Contact | Steven Kachelmeyer |
| Correspondent | Steven Kachelmeyer GENERAL ELECTRIC COMPANY 3000 N. GRANDVIEW BLVD., W-709 Waukesha, WI 53188 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-26 |
| Decision Date | 2011-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121064 | K103485 | 000 |
| 00840682117852 | K103485 | 000 |