MAMMOMAL INSPIRATION— 510(k) K122286
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K122286 for MAMMOMAL INSPIRATION, Substantially Equivalent on 2013-02-22. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mavern, PA, US
Recent devices under product code MUE
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K122286
K-number listed on FDA's recall record- Z-1118-2017 — Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
- Z-0523-2015 — Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
- Z-0086-2015 — Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
- Z-1638-2014 — MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
- Z-1694-2013 — Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122286.
Data sourced from openFDA. This site is unofficial and independent of the FDA.