510(k) K220630
- Device
- TorchTM Software
- Applicant
- Voximetry, Incorporated
- 510(k) number
- K220630
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-28
- Date received
- 2022-03-04
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Sue Wallace
- Address
- 8517 Excelsior Dr., Suite 207 Madison WI US 53717 53717
FDA Registration Numbers
- 3025602618
- 3004957385
- 1528142
- 3026612481
- 3017435704
- 3003895711
- 3033524690
- 3019844085
- 2027062
- 3030977776
- 3014954414
- 3033527282
- 3018133052
- 3011545155
- 3017210169
- 3007137598
- 3011307657
- 1834331
- 3036495186
- 3006260740
- 3032367
- 3031024978
- 3018405359
- 1063008
- 3011411309
- 3004434200
- 3020162557
- 3008487708
- 3042369547
- 9614981
- 3014809646
- 3016090213
- 3030228575
- 3011706018
- 1125622
- 3009293341
- 3007545404
- 2954358
- 3017058304
- 3019878658
- 1045254
- 3023546785
- 3021032044
- 3018733944
- 8010177
- 3006551230
- 3013427569
- 3009048384
- 3011221136
- 3010331645
- 3030228551
- 3014132130
- 3008840981
- 3007734888
- 8043933
- 3033508292
- 3017585294
- 3026309987
- 3007603826
- 9611343
- 3003202425
- 2183449
- 1723170
- 3003370689
- 3011189058
- 3008962159
- 3006621332
- 3038187462
- 2126677
- 3014146081
- 3030089065
- 3013552417
- 3025343020
- 3027329005
- 3021625328
- 3030979155
- 3004537781
- 3013041594
- 3009196021
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860010685402 | Torch | Voximetry, Inc. | 2023-02-13 |
Other 510(k) Records For Product Code LLZ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K260479 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 |