510(k) K250911
- Device
- MOSkin Radiation Measurement System
- Applicant
- Electrogenics Labs, Ltd.
- 510(k) number
- K250911
- Product code
- IYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-17
- Date received
- 2025-03-26
- Regulation
- 892.5050
- Classification name
- Accelerator, Linear, Medical
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- David Rundell
- Address
- Suite 1, Level 10 76 Berry St. North Sydney AU 2060 2060
FDA Registration Numbers
- 9613183
- 1450662
- 3016686005
- 3015620182
- 3012205931
- 1932738
- 3003793371
- 3007615597
- 3022719374
- 3015621321
- 3019552217
- 1651102
- 1526854
- 3001722928
- 2183744
- 3009894282
- 3009039068
- 3009077524
- 3013012623
- 3016591365
- 3027080417
- 3002808157
- 3015548663
- 3033484057
- 3025765259
- 3010875109
- 2184007
- 3015232217
- 1000162206
- 3004753785
- 3007350713
- 2182762
- 1123169
- 9616684
- 3012631246
- 3007546534
- 3005099803
- 3006621300
- 3002807314
- 9614952
- 1530561
- 3003803149
- 3010625741
- 2155
- 3004580128
- 3011716550
- 3006073271
- 8043933
- 3008317830
- 3013410552
- 3009649442
- 3009773332
- 9710332
- 3003094912
- 3007165183
- 3015496236
- 3003768277
- 3014428919
- 9681124
- 3009754495
- 3009394603
- 2431392
- 3026961165
- 3004637983
- 3006981798
- 3022973841
- 3014113695
- 3004962788
- 3003477135
- 3014404697
- 3031194398
- 3012039133
- 1720929
- 1055485
- 3018004899
- 9614584
- 3006405073
- 9617016
- 1647149
- 1000523114
- 2134494
- 1220477
- 3003586672
- 1721113
- 2030598
- 3010701021
- 2939248
- 3006946288
- 3004363352
- 3042022819
- 3004608878
- 3004832819
- 3008706707
- 1722661
- 3007037519
- 3003873069
- 1038814
- 3016602874
- 3038289344
- 3007791541
- 3015119628
- 2436865
- 9681134
- 3010123525
- 1219183
- 3008191247
- 3009140718
- 2247992
- 3030077501
- 3009302839
- 3006894636
- 3009607881
- 2916710
- 3018094310
- 3003418325
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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