510(k) K262060
- Device
- 3D-RD-S
- Applicant
- Radiopharmaceutical Imaging & Dosimetry, LLC
- 510(k) number
- K262060
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-04
- Date received
- 2026-06-18
- 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
- N
Applicant Contact#
- Contact
- Nadine Bonds
- Address
- 1800 Gough St. Baltimore MD US 21231 21231
FDA Registration Numbers#
- 3013427569
- 3004363352
- 3009555440
- 8043933
- 3011015597
- 1226544
- 3008481104
- 3015173183
- 3015153469
- 3005156333
- 3007038409
- 3030228575
- 9613445
- 3005718816
- 3011713200
- 3026606306
- 3006542593
- 3012916784
- 3032008018
- 3003477135
- 8020021
- 3015536273
- 3030446846
- 3004755841
- 3009293341
- 3014498512
- 3006738448
- 1000314502
- 3019878714
- 3033527273
- 3017155477
- 3033527282
- 3026309987
- 3010119782
- 3006209933
- 3009238185
- 3004962788
- 3015537315
- 3007005340
- 9612330
- 3013839079
- 3011221522
- 3018094310
- 3010956703
- 3003412859
- 3044776706
- 3011724582
- 3013503781
- 3015961056
- 3014146081
- 3015464948
- 3007867778
- 3001106601
- 3019834893
- 3023217364
- 3026970882
- 3011545155
- 3006165260
- 3007441485
- 2032350
- 3010493171
- 3014680735
- 3013501671
- 1064396
- 3003768251
- 3016727312
- 3027605321
- 1720929
- 3001722928
- 9615992
- 3019252669
- 3005225421
- 3006610845
- 3044519982
- 9616760
- 3017210169
- 9614209
- 3018302800
- 3016851379
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 |