# K173408: Mammomat Revelation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Mar 21, 2018 after 140 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941191 (1995). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123520: Mammomat Inspiration Prime, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.
- K122836: Affirm Breast Biopsy Guidance System, Lorad, A Hologic Co. (2013) Summary page 5.
- K123873: Contrast Enhanced Digital Mammography, Hologic, Inc. (2013) Summary page 5.

## Most influential descendants
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own
- 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
- May 7, 2020 · Class II · Z-2388-2020: If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 
- Jul 23, 2019 · Class II · Z-0160-2020: An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases

## 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/K173408
Methodology: https://510kreport.com/methodology