510(k) K092547
- Device
- DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX
- Applicant
- DENTIMAX
- 510(k) number
- K092547
- Product code
- MUJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-30
- Date received
- 2009-08-19
- Regulation
- 892.5050
- Classification name
- System, Planning, Radiation Therapy Treatment
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KORINA A AKHONDZADEH
- Address
- 6965 El Camino Real Suite 105-482 Carlsbad CA US 92009 92009
FDA Registration Numbers#
- 3000190675
- 3038718579
- 1226003
- 2032641
- 2024980
- 3014544225
- 3013186032
- 3010972172
- 1054713
- 3002819275
- 9615832
- 3018999255
- 3013651568
- 1523530
- 3017403245
- 9611036
- 3014398772
- 3010445368
- 3022107311
- 9611445
- 8030876
- 3013039893
- 3015376465
- 3034604691
- 3031823608
- 3020117925
- 3043226252
- 3005581016
- 3013503781
- 3021551875
- 3013779985
- 3012421607
- 2424472
- 3029916103
- 3021736604
- 3030126955
- 8044167
- 3004765453
- 3007007357
- 3007515144
- 3015464948
- 8043962
- 3003528079
- 3007065358
- 2024949
- 3009608361
- 3015509619
- 3009196578
- 3014683120
- 3008361230
- 3005383085
- 3010281549
- 3002807636
- 1032227
- 3012649815
- 3008770655
- 3003314115
- 3010609444
- 9615782
- 3008252267
- 3011471624
- 3008313821
- 3004706313
- 3003934980
- 3002994636
- 3016875543
- 3007538876
- 3006540014
- 3009048384
- 3025442726
- 3012187973
- 3013360312
- 3005843418
- 2428225
- 3010476612
- 3042046320
- 3013511605
- 3009598746
- 1725006
Source Documents#
Other 510(k) Records For Product Code MUJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | Philips Medical Systems Nederland B.V. | 2026-05-27 |
| K252784 | eXaSkin Plus | Anatomical Geometry S.L. | 2026-05-22 |
| K253078 | ART.1-US | Seetreat Pty, Ltd. | 2026-05-14 |
| K252304 | syngo.via RT Image Suite VC10 | Varian Medical Systems, Inc. | 2026-03-18 |
| K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| K252002 | Monaco RTP System (6.3) | Elekta Solutions AB | 2026-02-19 |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 2025-12-23 |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) | 2025-12-22 |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 2025-12-19 |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory | 2025-11-20 |
| K250064 | Dose+ (1.0) | Mvision AI OY | 2025-09-04 |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG | 2025-06-17 |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (PUBL) | 2025-04-17 |
| K242748 | Oncospace | Oncospace, Inc. | 2025-04-11 |
| K240398 | RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 | RaySearch Laboratories AB (PUBL) | 2025-04-04 |
Legacy Summary#
summary
FDA Review#
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