510(k) K254096
- Device
- VELMENI for DENTISTS (V4D) 3D
- Applicant
- Velmeni, Inc.
- 510(k) number
- K254096
- Product code
- QIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-23
- Date received
- 2025-12-19
- 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
- N
Applicant Contact#
- Contact
- Mini Suri
- Address
- 333 W. Maude Ave. Sunnyvale CA US 94085 94085
FDA Registration Numbers#
- 3015763655
- 3017167291
- 3013844297
- 3024820186
- 3004977335
- 3016446349
- 3002808157
- 9710602
- 9680269
- 3033527241
- 3011015597
- 3013552417
- 1644408
- 3020928588
- 3030412475
- 3027645731
- 3001722928
- 3015537315
- 3042248552
- 2126677
- 3019541896
- 3009196578
- 9612283
- 9611343
- 2032350
- 3043494619
- 3033527283
- 3042852277
- 3016585383
- 3011205675
- 3015425142
- 3016819165
- 3035950510
- 3007194257
- 3011763071
- 3020703662
- 3016461002
- 3018302800
- 3010952312
- 3000976525
- 8020021
- 1000432246
- 3006209933
- 3021032044
- 3012761544
- 3019878658
- 3028006458
- 3008284470
- 1818910
- 3007734888
- 3012987001
- 3011189058
- 3025430791
- 3027977501
- 3042955884
- 1423253
- 3035386366
- 3042902406
- 3015276088
- 3014310698
- 3017210169
- 9710090
- 3017173128
- 3031569584
- 3021887566
- 9680825
- 3005225421
- 3014938447
- 3003775006
- 3014678441
- 3014146081
- 3007630531
- 3010342382
- 3009731198
- 3009758186
- 3021907554
- 3024972425
- 3017426576
- 3025343020
Source Documents#
Other 510(k) Records For Product Code QIH#
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| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2026-06-11 |