510(k) K151212
- Device
- Ziostation2
- Applicant
- QI IMAGING, LLC
- 510(k) number
- K151212
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-04
- Date received
- 2015-05-06
- 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
- RICHARD BALL
- Address
- 1235 Radio Rd., Suite 110 Redwood City CA US 94065 94065
FDA Registration Numbers#
- 3006611212
- 3010687441
- 8022257
- 3011706018
- 3007137598
- 3023003446
- 3006738448
- 3006123366
- 9612330
- 3027158439
- 1000432246
- 3013283620
- 3012391689
- 3018133052
- 3008364043
- 1825014
- 3015612252
- 3014343888
- 1054415
- 9680497
- 3014232555
- 3019216
- 3013427569
- 3005517190
- 3012322232
- 3014146081
- 3015536273
- 3012761544
- 3002808157
- 3030179922
- 3005202320
- 3005916315
- 3004504920
- 3005930550
- 3011114764
- 1226773
- 3038187462
- 3007120336
- 3000237660
- 3010656400
- 3012448806
- 9615916
- 3019006180
- 3025602618
- 3009048384
- 3011657336
- 3007545404
- 3014498512
- 3013634985
- 3011205675
- 3021559833
- 2124215
- 3005919188
- 3008496839
- 3013511605
- 3033527282
- 1724955
- 3016579137
- 2031081
- 1056553
- 3016446349
- 3016832577
- 3018733944
- 1063008
- 3030228551
- 3003768251
- 9611992
- 3005914761
- 3004884150
- 3014132130
- 3022435840
- 3006579682
- 3010684280
- 3027605321
- 3022973841
- 2126677
- 3014639846
- 9614587
- 3020704423
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2026-09-18 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-09-15 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026-09-15 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026-09-04 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026-08-17 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | 2026-08-14 |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026-08-12 |
| 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 |
Legacy Summary#
summary
FDA Review#
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