FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE
K Number: K050667
·
Decision Mar 29, 2005
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
14
Basic Information
- Device Name
- R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE
- K Number
- K050667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R2 TECHNOLOGY, INC.
- Date Received
- March 15, 2005
- Decision Date
- March 29, 2005
- 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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Other Clearances by R2 TECHNOLOGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K051743 | R2 BREAST IMAGING WORKSTATION | Jul 25, 2005 | Substantially Equivalent |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR | Jun 8, 2004 | Substantially Equivalent |
| K040028 | CA-1500 | Jan 22, 2004 | Substantially Equivalent |
| K023003 | IMAGECHECKER-CT WORKSTATION | Nov 20, 2002 | Substantially Equivalent |