510(k) K222406
- Device
- Clarius AI
- Applicant
- Clarius Mobile Health Corp.
- 510(k) number
- K222406
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-23
- Date received
- 2022-08-09
- Regulation
- 892.2050
- Classification name
- Automated Radiological Image Processing Software
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Agatha Szeliga
- Address
- 130-2985 Virtual Way Vancouver CA V5M 4X7 V5M 4X7
FDA Registration Numbers#
- 3007675959
- 3003775006
- 3017487805
- 3044737887
- 3042852277
- 3015169361
- 3025343020
- 3019541896
- 9710090
- 3016461002
- 1000432246
- 3013497030
- 3010119782
- 3042902406
- 2936485
- 3005403518
- 3005930550
- 3014146081
- 3015763655
- 3004972322
- 3028006458
- 3002183074
- 3017167291
- 3012747207
- 3016824824
- 3027347389
- 1836549
- 3003899230
- 3015425142
- 3005383085
- 3014745562
- 8043836
- 3018733944
- 3038177848
- 3036756245
- 3000126629
- 3016759115
- 3031915908
- 3035373446
- 9616047
- 9680825
- 3017058304
- 3014310698
- 3007545404
- 9612283
- 3015276088
- 3034527804
- 3043625056
- 3013844297
- 3002808157
- 3013561205
- 3025603301
- 3003768277
- 3007194257
- 3042175844
- 3014809646
- 3017936978
- 3007301305
- 3035455070
- 2032350
- 3017936680
- 3013410552
- 3009731198
- 3022973841
- 3007734888
- 3014938447
- 3018094310
- 3039211310
- 3036725840
- 9710122
- 3015612252
- 3014665798
- 3035386366
- 3006209933
- 3030598283
- 3008496839
- 3010703925
- 2126677
- 3016585383
Source Documents#
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