510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Philips Health Care

Bothell, WA, US

Philips Health Care appears in FDA device records in Bothell, WA. FDA records list 20 510(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
20
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 20 510(k) clearances for Philips Health Care between 2011 and 2020. The busiest year on record is 2012, with 5. The most recent is 2020, with 3.

Clearances by year, as a table
510(k) clearance decisions for Philips Health Care, by decision year
YearClearances
20111
20125
20132
20151
20163
20172
20193
20203
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K2013523D Auto LAALLZSubstantially Equivalent
K200974QLAB Advanced Quantification SoftwareQIHSubstantially Equivalent
K200179Collaboration LiveLLZSubstantially Equivalent
K191647QLAB Advanced Quantification SoftwareQIHSubstantially Equivalent
K192226Lumify Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K190913QLAB Advanced Quantification Software 13LLZSubstantially Equivalent
K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K171314QLAB Advanced Quantification SoftwareLLZSubstantially Equivalent
K163020Xperius Ultrasound SystemIYNSubstantially Equivalent
K162549Lumify Ultrasound SystemIYNSubstantially Equivalent
K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K153480ClearVue850 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K132087PERCUNAV SYSTEMJAKSubstantially Equivalent
K130159QLAB QUANTIFICATION SOFTWARE HEART MODELLLZSubstantially Equivalent
K121498PERCUNAVJAKSubstantially Equivalent
K121638ST80I STRESS TEST SYSTEMDQKSubstantially Equivalent
K120855INTELLISPACE ECGDQKSubstantially Equivalent
K120321CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially Equivalent
K112959CALG-STR EXERCISE ECG ANALYSIS ALGORITHMDPSSubstantially Equivalent
K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TLNHSubstantially 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

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