Diagnostic Ultrasonic Transducer, Robotic
The Diagnostic Ultrasonic Transducer, Robotic (product code OQQ) is a robotic ultrasound transducer intended for diagnostic ultrasonic imaging or monitoring applications. It is designed to be used in robotic-assisted environments for non-invasive imaging of internal body structures. As an FDA Class 2 device under regulation 892.1570, it requires 510(k) premarket clearance and falls within the Radiology medical specialty. The device is eligible for third-party 510(k) review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OQQ
- Device Class
- FDA class 2
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
Definition
Diagnostic ultrasonic imaging or monitoring.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092164 | TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA | May 13, 2010 | Substantially Equivalent | Shenzhen Delicate Electronics Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.