510(k) clearances

MRIA Radiation Therapy Information System (MRIA)

Manteia Technologies Co., Ltd. · Radiology

K260733Substantially EquivalentTraditionalIYE
Open FDA's page for this record
Third party flag
N
City
Xiamen
Advisory committee description
Radiology
Address 1
Unit 3001-3005, #5 Huizhan N. Rd.
Statement or summary
Summary
Product code
IYE
Zip code
361000
Applicant
Manteia Technologies Co., Ltd.
Decision date
2026-08-26
Decision code
SESE
Country code
CN
Device name
MRIA Radiation Therapy Information System (MRIA)
Advisory committee
RA
Contact
Chao Fang
K number
K260733
Date received
2026-03-06
Review advisory committee
RA
Postal code
361000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Accelerator, Linear, Medical
Medical specialty description
Radiology
Regulation number
892.5050
Device class
2
Registration number
3003803149, 3013410552, 3010625741, 9681134, 3009649442, 9614584, 3006405073, 9710332, 1647149, 3001722928, 3004580128, 3009754495, 3004363352, 3009894282, 1450662, 3031194398, 3002808157, 3007165183, 1530561, 3009302839, 3003873069, 8043933, 3015621321, 3033484057, 3009140718, 1722661, 3006621300, 1651102, 3042022819, 3022719374, 3015548663, 1721113, 3003094912, 3026961165, 3006981798, 1219183, 3009039068, 3004832819, 9617016, 3016591365 +75 more
FEI number
1000143606, 3003803149, 3013410552, 3010625741, 3002807880, 3009649442, 3006405073, 3001722928, 3003251135, 3004580128, 3009754495, 3004363352, 3009894282, 1000227792, 1000518731, 3000253133, 1450662, 3031194398, 3002808157, 3007165183, 3009302839, 3002619595, 3003873069, 3015621321, 3002619738, 3033484057, 3009140718, 3006621300, 3042022819, 3022719374, 3015548663, 1721113, 3007360740, 3003094912, 3026961165, 3006981798, 1219183, 3009039068, 3004832819, 3016591365 +75 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.