FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
K Number: K091518
·
Decision Jun 18, 2009
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
6
Review Days
27
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Basic Information
- Device Name
- CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
- K Number
- K091518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mcube Technology Co., Ltd.
- Date Received
- May 22, 2009
- Decision Date
- June 18, 2009
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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|---|---|---|---|
| K201995 | CUBEScan BioCon-1100 | Aug 19, 2020 | Substantially Equivalent |
| K200749 | CUBEScan BioCon-900S | May 19, 2020 | Substantially Equivalent |
| K200548 | CUBEScan BioCon-1100 | Mar 27, 2020 | Substantially Equivalent |
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| K111021 | CUBESCAN / BIOCON-700 | Apr 27, 2011 | Substantially Equivalent |