The following data is part of a premarket notification filed by Scanmed, Llc with the FDA for Prostatid.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860009082618 | K212783 | 000 |
00860009082625 | K212783 | 000 |
00860009082601 | K212783 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PROSTATID 90324153 not registered Live/Pending |
Bot Image, Inc. 2020-11-17 |