FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
SECTRA MICRODOSE MAMMOGRAPHY
K Number: K110025
·
Decision Apr 28, 2011
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
5
Review Days
115
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Basic Information
- Device Name
- SECTRA MICRODOSE MAMMOGRAPHY
- K Number
- K110025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sectra Imtec AB
- Date Received
- January 3, 2011
- Decision Date
- April 28, 2011
- Product Code
- MUE
- 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 |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
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Other Clearances by Sectra Imtec AB
| K Number | Device Name | ||
|---|---|---|---|
| K081469 | SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2 | Jun 12, 2008 | Substantially Equivalent |
| K063093 | SECTRA WORKSTATION, VERSION 11.1 | Nov 7, 2006 | Substantially Equivalent |
| K051315 | MODIFICATION TO: SECTRA IDS5 WORKSTATION | Jun 15, 2005 | Substantially Equivalent |
| K050196 | SECTRA IDS5 WORKSTATION | Feb 24, 2005 | Substantially Equivalent |