510(k) clearances

ResolutionMD

ResolutionMD, Inc. · Radiology

K260500Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Calgary
Advisory committee description
Radiology
Address 1
Suite 314, 1212 31 Ave. NE
Statement or summary
Summary
Product code
LLZ
Zip code
T2E 7S8
Applicant
ResolutionMD, Inc.
Decision date
2026-07-21
Decision code
SESE
Country code
CA
Device name
ResolutionMD
Advisory committee
RA
Contact
Sharon Cholowsky
K number
K260500
Date received
2026-02-13
Review advisory committee
RA
Postal code
T2E 7S8
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Image Processing, Radiological
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
3006611212, 3010687441, 8022257, 3011706018, 3007137598, 3023003446, 3006738448, 3006123366, 9612330, 3027158439, 1000432246, 3013283620, 3012391689, 3018133052, 3008364043, 1825014, 3015612252, 3014343888, 1054415, 9680497, 3014232555, 3019216, 3013427569, 3005517190, 3012322232, 3014146081, 3015536273, 3012761544, 3002808157, 3030179922, 3005202320, 3005916315, 3004504920, 3005930550, 3011114764, 1226773, 3038187462, 3007120336, 3000237660, 3010656400 +596 more
FEI number
3006611212, 3010687441, 3011706018, 3007137598, 3023003446, 3002807692, 3006738448, 3003714383, 3006123366, 3027158439, 3002087856, 1000432246, 3002807880, 3013283620, 3012391689, 3018133052, 3008364043, 1825014, 3015612252, 3014343888, 3014232555, 3003190524, 3019216, 3013427569, 3005517190, 3012322232, 3004571294, 3014146081, 1000139922, 3015536273, 3002626007, 3012761544, 3002808157, 3030179922, 3005202320, 3005916315, 3004504920, 3005930550, 3011114764, 3038187462 +596 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.