FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AQUARIUS WORKSTATION
K Number: K011142
·
Decision May 8, 2001
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
7
Review Days
25
Basic Information
- Device Name
- AQUARIUS WORKSTATION
- K Number
- K011142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TERARECON, INC.
- Date Received
- April 13, 2001
- Decision Date
- May 8, 2001
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | Dec 24, 2013 | Substantially Equivalent |
| K121916 | INTUITION | Apr 2, 2013 | Substantially Equivalent |
| K061214 | AQUARIUSAPS SERVER | May 15, 2006 | Substantially Equivalent |
| K012086 | AQUARIUSNET SERVER | Sep 13, 2001 | Substantially Equivalent |
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | May 26, 2000 | Substantially Equivalent |
| K974307 | RTR-2000/RTR-4000 | Feb 13, 1998 | Substantially Equivalent |