510(k) clearances

SET-5002

Shimadzu Corporation Medical Systems Division · Radiology

K240827Substantially EquivalentAbbreviatedKPS
Open FDA's page for this record
Third party flag
N
City
Kyoto
Advisory committee description
Radiology
Address 1
1, Nishinokyo-Kuwabaracho, Nakagyoku
Statement or summary
Summary
Product code
KPS
Zip code
604-8511
Applicant
Shimadzu Corporation Medical Systems Division
Decision date
2024-05-24
Decision code
SESE
Country code
JP
Device name
SET-5002
Advisory committee
RA
Contact
Koichi Kataoka
K number
K240827
Date received
2024-03-26
Review advisory committee
RA
Postal code
604-8511
Decision description
Substantially Equivalent
Clearance type
Abbreviated
Harmonized identifiers (openFDA)
Device name
System, Tomography, Computed, Emission
Medical specialty description
Radiology
Regulation number
892.1200
Device class
2
Registration number
2320968, 2031050, 3027338963, 9617978, 3010703925, 3029521953, 1066019, 3017375271, 3018788582, 3010398867, 2247992, 3002808157, 3006209933, 3026047529, 3003477135, 9710645, 3009196578, 3031503890, 3038191646, 3013679558, 3022742930, 3011015597, 3026391023, 2126677, 3015777306, 3021032044, 3016007746, 3012690638, 3014343100, 3008962177, 3007545404, 3009136051, 3027339477, 3000126629, 2134213, 3034246184, 3012085143, 3004504920, 3008355361, 3014954414 +46 more
FEI number
3027338963, 3010703925, 3008581796, 3029521953, 3003079232, 3017375271, 3018788582, 1000571342, 3010398867, 3002808157, 3002808382, 3003015552, 3006209933, 3026047529, 3003477135, 3009196578, 3031503890, 3038191646, 3013679558, 3022742930, 3011015597, 3000210013, 3026391023, 3002175190, 2126677, 3015777306, 3021032044, 3016007746, 3012690638, 3002831423, 3014343100, 3001654007, 3008962177, 3007545404, 3009136051, 3027339477, 3000126629, 3034246184, 3012085143, 3004504920 +46 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.