510(k) clearances

CANON Fundus Camera CR-10 (CR-10)

Canon, Inc. · Ophthalmic

K241049Substantially EquivalentSpecialHKI
Open FDA's page for this record
Third party flag
N
City
Kawasaki
Advisory committee description
Ophthalmic
Address 1
9-1, Imaikami-Cho, Nakahara-Ku
Statement or summary
Summary
Product code
HKI
Zip code
2118501
Applicant
Canon, Inc.
Decision date
2024-05-15
Decision code
SESE
Country code
JP
Device name
CANON Fundus Camera CR-10 (CR-10)
Advisory committee
OP
Contact
Shigeo Watanabe
K number
K241049
Date received
2024-04-17
Review advisory committee
OP
Postal code
2118501
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Camera, Ophthalmic, Ac-Powered
Medical specialty description
Ophthalmic
Regulation number
886.1120
Device class
2
Registration number
8010482, 9616199, 8030392, 3011223751, 3009746052, 3012162565, 3038356864, 3006087789, 1000391004, 3038614464, 9615030, 3013403214, 3010792309, 3010069263, 3010202439, 2020550, 3010363436, 9612197, 2080939, 3005950902, 2918630, 3007710608, 2521877, 3008729548, 3009990264, 3016589969, 2320749, 3008252121, 3008396732, 3038790635, 1054713, 3002807715, 3014342096, 3015972897, 1000181430, 3009173773, 2242863, 3013158193, 9614661, 3007237389 +27 more
FEI number
3011223751, 3009746052, 3012162565, 3038356864, 3006087789, 1000391004, 3038614464, 3013403214, 1000122772, 3010792309, 3010069263, 2020550, 3010363436, 2080939, 3001362763, 3007475226, 3005950902, 1000292048, 1000175127, 2918630, 3007710608, 2521877, 3003004358, 1000114111, 3008729548, 3009990264, 3016589969, 3008252121, 1000582291, 3008396732, 3038790635, 3002807715, 3014342096, 3015972897, 1000181430, 3009173773, 2242863, 3013158193, 3002807554, 3007237389 +26 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.