FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K Number: K110717
·
Decision Dec 23, 2011
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
27
Review Days
283
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Basic Information
- Device Name
- KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
- K Number
- K110717
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Konica Minolta Medical & Graphic, Inc.
- Date Received
- March 15, 2011
- Decision Date
- December 23, 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 Konica Minolta Medical & Graphic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130936 | AERODR SYSTEM WITH P-31 | Aug 22, 2013 | Substantially Equivalent |
| K123499 | AEROPILOT | Dec 20, 2012 | Substantially Equivalent |
| K120752 | AERODR STITCHING SYSTEM | Jun 8, 2012 | Substantially Equivalent |
| K121109 | AERODR X70 | May 23, 2012 | Substantially Equivalent |
| K120477 | AEROSYNC FOR AERODR SYSTEM | Apr 9, 2012 | Substantially Equivalent |
| K120131 | REGIUS SIGMA2 | Feb 10, 2012 | Substantially Equivalent |
| K113248 | AERODR SYSTEM WITH P-21 | Jan 17, 2012 | Substantially Equivalent |
| K103703 | REGUIS SIGMA | Jun 2, 2011 | Substantially Equivalent |
| K101842 | ACIES | Feb 4, 2011 | Substantially Equivalent |
| K102349 | AERODR SYSTEM | Nov 24, 2010 | Substantially Equivalent |