510(k) clearances

ScanDiags Ortho L-Spine MR-Q

Scandiags AG · Radiology

K242607Substantially EquivalentTraditionalQIH
Open FDA's page for this record
Third party flag
N
City
Wallisellen
Advisory committee description
Radiology
Address 1
Zwickyplatz 3
Statement or summary
Summary
Product code
QIH
Zip code
8304
Applicant
Scandiags AG
Decision date
2025-02-21
Decision code
SESE
Country code
CH
Device name
ScanDiags Ortho L-Spine MR-Q
Advisory committee
RA
Contact
Stefan Voser
K number
K242607
Date received
2024-09-03
Review advisory committee
RA
Postal code
8304
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3036502204, 3005403518, 1000432246, 9710090, 3018094310, 3028006458, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3010703925, 3008837339, 3003768277, 3018064242, 3044776706, 3015612252, 3010656400, 3019541896, 9680269, 3042248552, 3003899230, 3014310698, 3018302800, 1644408, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3016965352, 3002808157, 3004141078, 3016585383, 3020703662, 3006209933, 3019878658, 3008284470 +201 more
FEI number
3036502204, 3005403518, 1000432246, 3018094310, 3028006458, 3003405980, 3003310366, 3008729547, 3006165260, 3025602618, 3017976149, 3015169361, 3017058304, 3003309342, 3008837339, 3010703925, 3018064242, 3044776706, 3015612252, 3003408255, 3019541896, 3010656400, 3003899230, 3042248552, 3014310698, 3018302800, 3025110425, 3030088963, 3031915908, 3023217364, 3010398867, 3011063460, 3003377038, 3016965352, 3002808157, 3016585383, 3004141078, 3002808529, 3002808382, 3020703662 +201 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.