Koios DS
Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Koios Medical, Inc.
The following data is part of a premarket notification filed by Koios Medical, Inc. with the FDA for Koios Ds.
Pre-market Notification Details
| Device ID | K212616 |
| 510k Number | K212616 |
| Device Name: | Koios DS |
| Classification | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Applicant | Koios Medical, Inc. 242 West 38th Street, 14th Floor New York, NY 10018 |
| Contact | Patricia Setti-laperch |
| Correspondent | Patricia Setti-laperch Koios Medical, Inc. 242 West 38th Street, 14th Floor New York, NY 10018 |
| Product Code | POK |
| CFR Regulation Number | 892.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2021-12-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002545714 | K212616 | 000 |
Trademark Results [Koios DS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KOIOS DS 88421199 not registered Live/Pending |
KOIOS MEDICAL, INC 2019-05-08 |
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