Atlas FDA

UROSKOP OMNIA

FDA 510(k) clearance K101491 · decided 2010-06-30

Clearance details

K-number
K101491
Device name
UROSKOP OMNIA
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2010-06-01
Decision date
2010-06-30
Days to decision
29 days
Clearance type
Special
Product code
JAA
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mavern, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
UROSKOP Omnia. Model Number: 10094910 recall (Z-1981-2025)Siemens Medical Solutions USA, Inc2025-06-17
UROSKOP Omnia Max. Model Number: 10762473 recall (Z-1982-2025)Siemens Medical Solutions USA, Inc2025-06-17
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily fo recall (Z-1670-2015)Siemens Medical Solutions USA, Inc2015-05-23
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic recall (Z-0004-2015)Siemens Medical Solutions USA, Inc2014-10-02
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to b recall (Z-2292-2014)Siemens Medical Solutions USA, Inc2014-09-10
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software version recall (Z-1845-2014)Siemens Medical Solutions USA, Inc2014-06-21
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G recall (Z-0140-2014)Siemens Medical Solutions USA, Inc2013-11-27
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia syste recall (Z-0374-2014)Siemens Medical Solutions USA, Inc2013-11-26
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software version recall (Z-0016-2014)Siemens Medical Solutions USA, Inc2013-11-01
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray i recall (Z-1159-2012)Siemens Medical Solutions USA, Inc2012-03-05

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21