510(k) clearances

RW-1

Mediott, Inc. · Radiology

K253029Substantially EquivalentTraditionalLLZ
Open FDA's page for this record
Third party flag
N
City
Shinjuku-Ku
Advisory committee description
Radiology
Address 1
18-2 Shitamachi, Akagi Kagura Sacas
Statement or summary
Summary
Product code
LLZ
Zip code
162-0803
Applicant
Mediott, Inc.
Decision date
2026-03-31
Decision code
SESE
Country code
JP
Device name
RW-1
Advisory committee
RA
Contact
Abe Takehiko
K number
K253029
Date received
2025-09-19
Review advisory committee
RA
Postal code
162-0803
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
3003412859, 3036725840, 3023217364, 8043933, 3016851379, 3021637148, 3010132318, 3026391019, 3045159436, 9615992, 3023266032, 3017936978, 3017489096, 3003768277, 3003402534, 3004526608, 3048085746, 3008027912, 1826555, 3006115340, 3004884150, 9614977, 3007137598, 3006990600, 1717344, 3017435704, 3025308066, 3012322232, 1000432246, 3011114764, 3009238185, 3004063527, 3014055202, 3013077751, 3010656400, 3006551157, 3006551230, 3011724582, 3009134655, 3010687441 +600 more
FEI number
3003405980, 3003412859, 3036725840, 3023217364, 3016851379, 3021637148, 3010132318, 3026391019, 3045159436, 3023266032, 3017936978, 3017489096, 3003402534, 1826555, 3004526608, 3048085746, 3008027912, 3006115340, 3004884150, 3007137598, 3006990600, 1717344, 3017435704, 3025308066, 3012322232, 1000432246, 3011114764, 3009238185, 3004063527, 3003719498, 3014055202, 3013077751, 3010656400, 3006551157, 3006551230, 3011724582, 3009134655, 3010687441, 3000219976, 3008962159 +600 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.