Device classification

Interventional Fluoroscopic X-Ray System

Radiology · 21 CFR 892.1650

Class IIProduct code OWB
Open FDA's page for this record
Third party flag
Y
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
OWB
Review panel
RA
Medical specialty
RA
Device name
Interventional Fluoroscopic X-Ray System
Medical specialty description
Radiology
Device class
2
Definition
Interventional fluoroscopy
Regulation number
892.1650
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K022322, K122457, K190768, K221344, K213455, K261413, K221335, K201156, K023178, K052412, K172863, K936180, K130893, K143225, K113027, K123508, K142243, K142273, K062647, K181830, K250010, K121444, K210054, K230950, K170144, K242731, K172700, K211191, K040675, K193326, K252500, K170800, K230185, K113403, K082243, K173664, K132094, K123529, K073543, K210900 +285 more
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.