FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K Number: K081843
·
Decision Jul 15, 2008
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
39
Review Days
15
Basic Information
- Device Name
- ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
- K Number
- K081843
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ALOKA CO., LTD.
- Date Received
- June 30, 2008
- Decision Date
- July 15, 2008
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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