← FDA Medical Device Classifications
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
POK · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2060
Classification
- FDA Product Code
POK- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 892.2060
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Assist users in characterizing lesions identified on acquired medical images
Market data
- Cleared 510(k) submissions
- 21
- Registered establishments
- 14
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown