Identity
- Trade Name
- VeraLook CTC CAD FDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review. FDA UDI
- Model / Reference
- V1.1 FDA UDI
- Description
- VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review. FDA UDI
Identifiers
- Catalog Number
- CT-102 FDA UDI
- Primary DI / UDI-DI
- 00858012005915 FDA UDI
- 510(k) Number
- K091529 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CT system application software
VeraLook CTC CAD by Icad, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CT system application software.
- QCT Bone Mineral Density Analysis Software — Mindways Software, Inc. · Class II
- AI-Rad Companion (Cardiovascular) — Siemens Healthcare · Class II
- syngo.CT Dual Energy — Siemens Healthcare · Class II
- Monarch™ Software Laptop v2.1.2 — Auris Health, Inc. · Class II
- LungPrint — VIDA DIAGNOSTICS · Class II
- QCT PRO 3D Volumetric Spine and CTXA Hip Software — Mindways Software, Inc. · Class II
- syngo.CT Extended Functionality — Siemens Healthcare · Class II
- syngo.via RT Image Suite — Siemens Healthcare · Class II
Cleared under the same submission
K091529 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icad, Inc.
Sources (1)
- FDA UDI 83bcfd97-9f72-492b-835f-016cbdb8a547 36 fields · synced May 30, 2026