ProstatID
by Scanmed, LLC
510(k) K212783
ProstatID is a Class II device made by Scanmed, LLC, cleared under FDA 510(k) K212783 on 8 Jul 2022, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212783 | Date8 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K212783
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QDQ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2090
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212783
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Bot Image, Inc. ProstatID™ | 580SW.01 / ProstatID™ | 00860009082618 | — | On the market |
| Bot Image, Inc. ProstatID™ | ProstatID™ | 00860009082625 | — | No longer on the market |
| Bot Image, Inc. ProstatID™ | ProstatID™ | 00860009082601 | — | No longer on the market |
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