510(k) K180129
- Device
- Imbio Segmentation Editing Tool Software
- Applicant
- Imbio, LLC
- 510(k) number
- K180129
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-03-16
- Date received
- 2018-01-17
- 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
- No
Applicant Contact#
- Contact
- Vipul Goel
- Address
- 807 Broadway St. NE, #350 Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 3010146120
- 3024820186
- 3030979155
- 1226773
- 2954358
- 3044519982
- 3017102960
- 3010966991
- 3016244609
- 3014678441
- 3007362683
- 1720929
- 3005904906
- 3008355361
- 3027338963
- 3004884150
- 3007005340
- 3004722076
- 3030982377
- 3010687441
- 3015895145
- 3013501671
- 1226003
- 3014132130
- 3015777306
- 1647172
- 2027062
- 3014809646
- 3006060685
- 3013077751
- 3015961056
- 9615010
- 3008007310
- 9615439
- 3017263724
- 3015232217
- 3045159436
- 3004755841
- 3014391847
- 3042204491
- 3000219976
- 3042480122
- 3025343020
- 3005180920
- 2183553
- 3029915548
- 3009555447
- 3027605321
- 3014639846
- 8043485
- 3018064242
- 3030412764
- 3007038409
- 3010533307
- 2531814
- 3011657336
- 3042957826
- 3011396687
- 9611343
- 3021163566
- 3005207094
- 3011706018
- 3006098230
- 3004009431
- 3014665798
- 3019216
- 3014398772
- 1423253
- 3020331900
- 3014343888
- 3002994636
- 3005156333
- 3011221136
- 3005919188
- 3011189058
- 1125622
- 3017936680
- 3010160527
- 3033525987
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| K260588 | Cleerly LABS | Cleerly, Inc. | 2026-07-29 |
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-07-24 |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | 2026-07-23 |
| K260500 | ResolutionMD | ResolutionMD, Inc. | 2026-07-21 |
| K262120 | Avara Viewer | Avara Software | 2026-07-10 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases