510(k) K220205
- Device
- 3D Anatomic Models
- Applicant
- Ricoh USA, Inc.
- 510(k) number
- K220205
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-03
- Date received
- 2022-01-25
- 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
- Gary Turner
- Address
- 5575 Venture Dr. Unit A Parma OH US 44130 44130
FDA Registration Numbers#
- 3024040179
- 2183449
- 3027977501
- 3032807464
- 9617277
- 3012470322
- 1226773
- 3021625328
- 3014262693
- 3023702877
- 1528142
- 9681475
- 8010177
- 3010132318
- 3013306229
- 3013695852
- 3007457520
- 3016555232
- 3005718816
- 3017991646
- 3025602618
- 3002672225
- 3018064242
- 3022973841
- 3005940400
- 3008012314
- 3026391019
- 3011724582
- 3007809729
- 3003941243
- 3004497354
- 3016446349
- 9680825
- 3015153469
- 3018733944
- 3021233709
- 9614977
- 3030982377
- 3014111222
- 3018302800
- 3019252669
- 3015276088
- 3034604691
- 3016007746
- 3011657336
- 3003895711
- 3029877582
- 3005877899
- 3009144915
- 3016450069
- 3009246966
- 3030088963
- 3009077524
- 3008962159
- 3014635169
- 3038189169
- 3025442726
- 2031966
- 3013844297
- 3014055202
- 3019269298
- 3003898228
- 3003775006
- 3010685285
- 3014391847
- 2027062
- 3030409224
- 9611992
- 2954921
- 3015777306
- 3013186032
- 3009140718
- 3006579682
- 3030179922
- 3010822102
- 3015516266
- 3047378919
- 3016851379
- 3045521711
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
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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