Atlas FDA

MAGNETOM SYMPHONY A TIM SYSTEM

FDA 510(k) clearance K050199 · decided 2005-02-18

Clearance details

K-number
K050199
Device name
MAGNETOM SYMPHONY A TIM SYSTEM
Applicant
Siemens Medical Solution
Decision
Substantially Equivalent
Date received
2005-01-28
Decision date
2005-02-18
Days to decision
21 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S006)Siemens Medical Solution2010-11-05
SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM (P030010/S005)Siemens Medical Solution2010-10-06
MAMMOMAT NOVATION DR (P030010/S004)Siemens Medical Solution2009-06-04
SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM (P030010/S003)Siemens Medical Solution2006-02-15
SIEMENS MAMMOMAT NOVATION FFDM SYSTEM (P030010/S001)Siemens Medical Solution2005-07-07
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010/S002)Siemens Medical Solution2005-06-20
SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P030010)Siemens Medical Solution2004-08-20