FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VOYAGER COMPACT IMAGING SYSTEM
K Number: K092182
·
Decision Oct 9, 2009
Classifications
1
FEI Numbers
345
Registration Numbers
346
Same Product Code
883
Applicant Total
3
Review Days
80
Basic Information
- Device Name
- VOYAGER COMPACT IMAGING SYSTEM
- K Number
- K092182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ardent Sound, Inc.
- Date Received
- July 21, 2009
- Decision Date
- October 9, 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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