Mammomat Revelation— 510(k) K173408
Substantially EquivalentSiemens Medi Cal Solutions, Inc.
FDA 510(k) clearance K173408 for Mammomat Revelation, Substantially Equivalent on 2018-03-21. Applicant: Siemens Medi Cal Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medi Cal Solutions, 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
- Malvern, PA, US
Recent devices under product code MUE
view allMore clearances from Siemens Medi Cal Solutions, 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 K173408
K-number listed on FDA's recall record- Z-2388-2020 — MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
- Z-0160-2020 — Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173408.
Data sourced from openFDA. This site is unofficial and independent of the FDA.