510(k) clearances

Ziehm Solo FD

Ziehm Imaging GmbH · Radiology

K234109Substantially EquivalentSpecialOWB
Open FDA's page for this record
Third party flag
N
City
Nuremberg
Advisory committee description
Radiology
Address 1
Lina-Ammon-Strasse 10
Statement or summary
Summary
Product code
OWB
Zip code
90471
Applicant
Ziehm Imaging GmbH
Decision date
2024-01-26
Decision code
SESE
Country code
DE
Device name
Ziehm Solo FD
Advisory committee
RA
Contact
Tsvetelina Milanova
K number
K234109
Date received
2023-12-27
Review advisory committee
RA
Postal code
90471
Decision description
Substantially Equivalent
Clearance type
Special
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.