← FDA Medical Device Classifications
Software For Visualization Of Vascular Anatomy And Intravascular Devices
PZO · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050
Classification
- FDA Product Code
PZO- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 892.2050
- Review panel
- CV
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Market data
- Cleared 510(k) submissions
- 10
- Registered establishments
- 3
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown