FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
K Number: K041380
·
Decision Jun 8, 2004
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
5
Review Days
14
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Basic Information
- Device Name
- IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
- K Number
- K041380
- 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
- May 25, 2004
- Decision Date
- June 8, 2004
- Product Code
- OEB
- 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 |
|---|---|---|---|
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 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 |
| K050667 | R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE | Mar 29, 2005 | Substantially Equivalent |
| K040028 | CA-1500 | Jan 22, 2004 | Substantially Equivalent |
| K023003 | IMAGECHECKER-CT WORKSTATION | Nov 20, 2002 | Substantially Equivalent |