510(k) K073704
- Device
- I-DIXEL
- Applicant
- J. MORITA USA, INC.
- 510(k) number
- K073704
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-21
- Date received
- 2007-12-31
- 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
- KEITH A BARRITT
- Address
- 1425 K St., NW, Suite 1100 Washington DC US 20005 20005
FDA Registration Numbers#
- 3016727312
- 1647172
- 3021233709
- 3017426576
- 1125622
- 3021625328
- 3019216
- 3042940623
- 3010966991
- 2433615
- 9614209
- 3005739655
- 3013342228
- 3006542593
- 3017936978
- 3003935342
- 3043532712
- 9616251
- 3045521711
- 3012569470
- 3011063460
- 3012516536
- 3017140520
- 3004972322
- 3003402534
- 3012345110
- 3009144915
- 2031081
- 2183301
- 1721964
- 3024040179
- 3012761544
- 3009756153
- 3009463023
- 9611992
- 3015777306
- 3016461002
- 3017448360
- 3008596921
- 3025308066
- 3013839079
- 9617840
- 3014498512
- 3015464948
- 3006611212
- 8043933
- 3013535906
- 3007734888
- 3008027912
- 3012391689
- 3004755841
- 3015276088
- 3032807464
- 3009196578
- 3009140718
- 3043840131
- 3004485675
- 2221819
- 3007675959
- 3010287737
- 3010157088
- 3021637148
- 3002579136
- 3025394753
- 3014232555
- 8030876
- 1066247
- 3004063527
- 3018302800
- 3007194257
- 3027605321
- 3005450718
- 3013912897
- 3004753388
- 8043836
- 1226544
- 3003604053
- 9615916
- 3009149931
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#
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