← FDA Medical Device Classifications
Display, Diagnostic Radiology
PGY · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050
Classification
- FDA Product Code
PGY- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 892.2050
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Market data
- Cleared 510(k) submissions
- 134
- Registered establishments
- 21
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown