FDA-Device2020-06-24Class II
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.
Siemens Medical Solutions USA, Inc
Hazard
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 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
Sold states
US Nationwide distribution.
Affected count
230 worldwide (64 US)
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2388-2020Don't want to check this manually?
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