Identity
- Trade Name
- Bot Image, Inc. FDA UDI
- Generic Name
- MRI image interpretive software FDA UDI
- Device Name
- ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform FDA UDI
- Model / Reference
- ProstatID™ FDA UDI
- Description
- ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009082601 FDA UDI
- 510(k) Number
- K212783 FDA UDI
- FDA Product Code
- QDQ FDA UDI
- GMDN Term
- MRI image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2090 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Bot Image, Inc. by Bot Image, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K212783 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bot Image, Inc.
Sources (1)
- FDA UDI efee4e08-eee5-4f90-98a7-6c45d97c0d98 35 fields · synced Jun 9, 2026