# K193166: MAMMOMAT Revelation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 12, 2020 after 210 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941191 (1995). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173408: Mammomat Revelation, Siemens Medi Cal Solutions, Inc. (2018) Summary page 4.

## Most influential descendants
- K233539: MAMMOMAT B.brilliant (2024), 1 descendant of its own
- K253678: MAMMOMAT B.brilliant (11372950) (2026), 0 descendants of its own
- K210955: Kubtec Mozart Supra (XPERT 84) Radiography System (2021), 0 descendants of its own
- K210957: Kubec Xpert 80 Radiography System (2021), 0 descendants of its own

## Recalls of this device
- Oct 24, 2025 · Class II · Z-0877-2026: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary

## Indications for use
The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be interpreted by either hard copy film or soft copy workstation. With Biopsy Option: The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

Source page: https://510kreport.com/device/K193166
Methodology: https://510kreport.com/methodology