← FDA Medical Device Classifications
Camera, Scintillation (Gamma)
IYX · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.1100
Classification
- FDA Product Code
IYX- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 892.1100
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 130
- Registered establishments
- 21
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown