The following data is part of a premarket notification filed by Optellum Ltd with the FDA for Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform.
| Device ID | K202300 |
| 510k Number | K202300 |
| Device Name: | Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform |
| Classification | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Applicant | Optellum Ltd Oxford Centre For Innovation, New Road Oxford, GB Ox1 1by |
| Contact | David Arrowsmith |
| Correspondent | David Arrowsmith Optellum Ltd Oxford Centre For Innovation, New Road Oxford, GB Ox1 1by |
| Product Code | POK |
| CFR Regulation Number | 892.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-13 |
| Decision Date | 2021-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B816VNC2P10 | K202300 | 000 |
| B816VNC2P30 | K202300 | 000 |