510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Siemens AG Medical Solutions

Forchheim, DE

Siemens AG Medical Solutions appears in FDA device records in Forchheim, DE. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
31
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 31 510(k) clearances for Siemens AG Medical Solutions between 2003 and 2015. The busiest year on record is 2008, with 5. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Siemens AG Medical Solutions, by decision year
YearClearances
20033
20042
20054
20062
20074
20085
20093
20103
20111
20121
20131
20141
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K143196syngo.CT Lung CADOEBSubstantially Equivalent
K130998SYNGO.VIA WEB VIEWERLLZSubstantially Equivalent
K123920SYNGO.VIALLZSubstantially Equivalent
K120331SYNGO CT DYNAMIC ANGIOJAKSubstantially Equivalent
K111079SYNGO.VIA WEB VIEWERLLZSubstantially Equivalent
K101666SYNGO. PLAZA VA20ALLZSubstantially Equivalent
K100637SYNGO.CT CORONARY ANALYSISJAKSubstantially Equivalent
K093612SYNGO.PLAZALLZSubstantially Equivalent
K092067ABVS WORKPLACELLZSubstantially Equivalent
K092519SYNGO.XLLZSubstantially Equivalent
K092013SYNGO VOLUME PERFUSION-CT BODYJAKSubstantially Equivalent
K082430SYNGO IMAGING XSLLZSubstantially Equivalent
K081734SYNGO IMAGING (VERSION V31)LLZSubstantially Equivalent
K072728SYNGO MULTIMODALITY WORKPLACELLZSubstantially Equivalent
K073418SYNGO IMAGING CCF VA10ALLZSubstantially Equivalent
K073238SYNGO VOLUME PERFUSION-CT NEUROJAKSubstantially Equivalent
K073373SYNGO VOLUME PERFUSION-CT BODYJAKSubstantially Equivalent
K0729091.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COILMOSSubstantially Equivalent
K071114SYNGO IMAGING (VERSION V30)LLZSubstantially Equivalent
K063762SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYJAKSubstantially Equivalent
K062673MODIFICATION TO SYNGO INSPACE 4DJAKSubstantially Equivalent
K061964SYNGO MULTIMODALITY WORKPLACELLZSubstantially Equivalent
K052775SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)LLZSubstantially Equivalent
K052461SYNGO IMAGING VERSION V20ALLZSubstantially Equivalent
K052029SYNGO CIRCULATIONJAKSubstantially Equivalent
K043469SYNGO INSPACE 4DJAKSubstantially Equivalent
K042832SIENET COSMOS (VERSION V15A)LLZSubstantially Equivalent
K042605COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYNWESubstantially Equivalent
K033832SYNGO PERFUSION-CTJAKSubstantially Equivalent
K033831SIENET COSMOSLLZSubstantially Equivalent
K033374LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYOEBSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain