Device System, Imaging, Tympanic Membrane And Middle Ear
The Device System, Imaging, Tympanic Membrane And Middle Ear is a Class 2 imaging device intended for use as a visualization tool for the human tympanic membrane and middle ear space, aiding clinicians in otological examination and assessment. It requires 510(k) clearance and is regulated under 21 CFR 892.1560, reviewed by the Ear, Nose, and Throat panel under the Radiology medical specialty classification. The product code is QJG. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QJG
- Device Class
- FDA class 2
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.