← FDA Medical Device Classifications
Device System, Imaging, Tympanic Membrane And Middle Ear
QJG · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1560
Classification
- FDA Product Code
QJG- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 892.1560
- Review panel
- EN
- Medical specialty
- Radiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
Market data
- Cleared 510(k) submissions
- 2
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown