FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOK7600W Wireless Flat Panel Detector
K Number: K190300
·
Decision Mar 13, 2019
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- BIOK7600W Wireless Flat Panel Detector
- K Number
- K190300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biokinemetrics, Inc.
- Date Received
- February 12, 2019
- Decision Date
- March 13, 2019
- Product Code
- MQB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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