510(k) clearances

Radiance V5

Gmv Soluciones Globales Internet S.A.U. · Radiology

K233236Substantially EquivalentTraditionalMUJ
Open FDA's page for this record
Third party flag
N
City
Tres Cantos
Advisory committee description
Radiology
Address 1
Calle De Isaac Newton, 11
Statement or summary
Summary
Product code
MUJ
Zip code
28760
Applicant
Gmv Soluciones Globales Internet S.A.U.
Decision date
2024-05-17
Decision code
SESE
Country code
ES
Device name
Radiance V5
Advisory committee
RA
Contact
Carlos Illana
K number
K233236
Date received
2023-09-28
Review advisory committee
RA
Postal code
28760
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Planning, Radiation Therapy Treatment
Medical specialty description
Radiology
Regulation number
892.5050
Device class
2
Registration number
3015777306, 3010123525, 3009090417, 3019834893, 3019543601, 3014425747, 3004580128, 3003586672, 2434141, 1038814, 3022719374, 9617978, 3003873069, 3009302839, 3030564015, 3007791541, 3014873236, 3003768277, 1651102, 3003418325, 2939248, 3006579682, 2916710, 3000126629, 3004561814, 3016602874, 3025765259, 3033527281, 3002808157, 3016686005, 9611894, 3023344262, 8043933, 3022745617, 3007037519, 3013410552, 3004363352, 3003793371, 2030598, 3012039133 +16 more
FEI number
3015777306, 3010123525, 3009090417, 3019834893, 3019543601, 3002807880, 3014425747, 3003586672, 3004580128, 3002802883, 2434141, 3022719374, 1038814, 3003873069, 3009302839, 3030564015, 3007791541, 3014873236, 3008581796, 3003418325, 2939248, 3006579682, 2916710, 3000126629, 3004561814, 3016602874, 3025765259, 3002807741, 3033527281, 3002808157, 3016686005, 3023344262, 3022745617, 3007037519, 3013410552, 3004363352, 3003793371, 3012039133, 3015232217, 1000518731 +16 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.