← FDA Medical Device Classifications
Device, Digital Image Storage, Radiological
LMB · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.2010
Classification
- FDA Product Code
LMB- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 892.2010
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Market data
- Cleared 510(k) submissions
- 55
- Registered establishments
- 59
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown