ProstatID
Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
ScanMed, LLC
The following data is part of a premarket notification filed by Scanmed, Llc with the FDA for Prostatid.
Pre-market Notification Details
| Device ID | K212783 |
| 510k Number | K212783 |
| Device Name: | ProstatID |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | ScanMed, LLC 9840 S 140 Street, Suite #8 Omaha, NE 68138 |
| Contact | Randall Jones |
| Correspondent | Carlee Seeba ScanMed, LLC 9840 S 140 Street, Suite #8 Omaha, NE 68138 |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-07-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009082618 | K212783 | 000 |
| 00860009082625 | K212783 | 000 |
| 00860009082601 | K212783 | 000 |
Trademark Results [ProstatID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROSTATID 90324153 not registered Live/Pending |
Bot Image, Inc. 2020-11-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.