FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AERODR SYSTEM WITH P-21
K Number: K113248
·
Decision Jan 17, 2012
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
27
Review Days
75
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Basic Information
- Device Name
- AERODR SYSTEM WITH P-21
- K Number
- K113248
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Konica Minolta Medical & Graphic, Inc.
- Date Received
- November 3, 2011
- Decision Date
- January 17, 2012
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 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 |
| K110717 | KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM | Dec 23, 2011 | 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 |