510(k) clearances

Zenition 90

Philips Medical Systems Nederlands B.V. · Radiology

K240224Substantially EquivalentAbbreviatedOWB
Open FDA's page for this record
Third party flag
N
City
Best
Advisory committee description
Radiology
Address 1
Veenpluis 6
Statement or summary
Summary
Product code
OWB
Zip code
5684PC
Applicant
Philips Medical Systems Nederlands B.V.
Decision date
2024-05-22
Decision code
SESE
Country code
NL
Device name
Zenition 90
Advisory committee
RA
Contact
Rahul Kumar Sinha
K number
K240224
Date received
2024-01-26
Review advisory committee
RA
Postal code
5684PC
Decision description
Substantially Equivalent
Clearance type
Abbreviated
Harmonized identifiers (openFDA)
Device name
Interventional Fluoroscopic X-Ray System
Medical specialty description
Radiology
Regulation number
892.1650
Device class
2
Registration number
3018094310, 3012624817, 3005172103, 3015223550, 3002672225, 3006972752, 3010703925, 3003768277, 3005706667, 3021559833, 3017375271, 3012957335, 3010398867, 2247992, 1054713, 3030412764, 3003477135, 3008284470, 3009196578, 3021060474, 3031503890, 3001722928, 3006544299, 3011015597, 3010462278, 3042175844, 3026391023, 3004977335, 3005843418, 3025394757, 3018596740, 3014343100, 3010162973, 1056553, 2031966, 3013184485, 3002466018, 3010685285, 1720753, 3027339477 +86 more
FEI number
3018094310, 3012624817, 3005172103, 3015223550, 3002672225, 3006972752, 3010703925, 3005706667, 3021559833, 3017375271, 3012957335, 3010398867, 3002808382, 3030412764, 3003477135, 3008284470, 3009196578, 3021060474, 3031503890, 3000209794, 3001722928, 3006544299, 3011015597, 3010462278, 3042175844, 3026391023, 3004977335, 3002619595, 3002175190, 3005843418, 3025394757, 3018596740, 3014343100, 3013184485, 3002466018, 3010685285, 1720753, 3000205591, 1000517638, 3027339477 +86 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.