510(k) K071436
- Device
- REGIUS UNITEA
- Applicant
- KONICA MINOLTA MEDICAL & GRAPHIC, INC.
- 510(k) number
- K071436
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-27
- Date received
- 2007-05-23
- 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
- RUSSELL MUNVES
- Address
- 140 E. 45th St., 25th Floor Two Grand Central Tower New York NY US 10017 10017
FDA Registration Numbers#
- 3006123366
- 3011724582
- 3030179922
- 9615916
- 3013844297
- 3021637148
- 3003769120
- 3005369776
- 3010111497
- 9614981
- 1724955
- 3015536273
- 3006165530
- 8030233
- 3032367
- 3010445368
- 3003989043
- 3047378919
- 3010157088
- 3011063460
- 3005202320
- 3004555721
- 3007120336
- 3003941243
- 2221819
- 3015763655
- 3009532935
- 3008962159
- 1032347
- 3029877582
- 3023702877
- 1834331
- 3003574171
- 1836549
- 3009489134
- 3009833070
- 3014680735
- 3015464948
- 3013634985
- 3017233423
- 3022435840
- 3033527283
- 3004730352
- 3027338963
- 3004063527
- 1066247
- 3030446518
- 3022973841
- 3012516536
- 3011713200
- 3017654247
- 3014663814
- 3015231789
- 3004993756
- 3006098230
- 3026391019
- 3030446846
- 3005706667
- 3045751562
- 3019257308
- 3012911444
- 2126677
- 9614977
- 1647172
- 8022257
- 3014232555
- 3010684280
- 3006990600
- 3002907620
- 3017058304
- 3017155477
- 3014635169
- 3013503781
- 3009555447
- 3010687441
- 9615010
- 3016965352
- 3008309062
- 3034604691
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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