The following data is part of a premarket notification filed by Sectra Ab with the FDA for Sectra Digital Pathology Module.
| Device ID | K193054 |
| 510k Number | K193054 |
| Device Name: | Sectra Digital Pathology Module |
| Classification | Digital Pathology Image Viewing And Management Software |
| Applicant | Sectra AB Teknikringen 20 Linkoping, SE 58330 |
| Contact | Edoardo Mastrovito |
| Correspondent | Peter Altman Peter Altman 14 Mercer Road Savannah, GA 31411 -1433 |
| Product Code | QKQ |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2020-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350092810197 | K193054 | 000 |
| 07350092810289 | K193054 | 000 |
| 07350092810333 | K193054 | 000 |
| 07350092810388 | K193054 | 000 |
| 07350092810425 | K193054 | 000 |
| 07350092810456 | K193054 | 000 |
| 07350092810487 | K193054 | 000 |