510(k) K200907
- Device
- Thales 3D Mr Scanner
- Applicant
- LAP GmbH Laser Applikationen
- 510(k) number
- K200907
- Product code
- IYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-06-03
- Date received
- 2020-04-06
- Regulation
- 892.5050
- Classification name
- Accelerator, Linear, Medical
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martin Pfabel
- Address
- Zeppelinstrasse 23 Lueneburg DE 21335 21335
FDA Registration Numbers#
- 3030077501
- 3004637983
- 3009607881
- 2134494
- 9614584
- 3005099803
- 3003803149
- 2155
- 3006621300
- 1450662
- 9613183
- 3006981798
- 9681134
- 1721113
- 3009773332
- 1038814
- 3015548663
- 3004363352
- 3003873069
- 3015621321
- 3002808157
- 1720929
- 3003768277
- 3012205931
- 1526854
- 9617016
- 3006073271
- 3006894636
- 3002807314
- 3003793371
- 1647149
- 3013410552
- 3018094310
- 3022973841
- 2247992
- 1000523114
- 3014428919
- 3019552217
- 2182762
- 3007350713
- 1055485
- 3009649442
- 2916710
- 2184007
- 3004962788
- 3007546534
- 3015620182
- 2939248
- 1220477
- 2431392
- 3042022819
- 3009077524
- 3027080417
- 3022719374
- 2183744
- 3006579682
- 3014113695
- 3007615597
- 3009894282
- 3008191247
- 2030598
- 3007037519
- 3018004899
- 1000162206
- 3003477135
- 3014404697
- 3008706707
- 3012039133
- 3016602874
- 1123169
- 1651102
- 3009754495
- 3013012623
- 1932738
- 3015232217
- 3031194398
- 3008317830
- 3010875109
- 3004832819
Source Documents#
Other 510(k) Records For Product Code IYE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252937 | ThinkQA 3 | Dosisoft SA | 2026-06-12 |
| K253004 | LUNA 3D | Lap GmbH Laser Applikationen | 2026-06-04 |
| K260792 | AerFrame Patient Immobilization System (AFPIS) | Stabilix, LLC | 2026-05-08 |
| K252258 | VERIQA RT EPID 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026-04-15 |
| K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | 2026-04-03 |
| K253012 | AlignRT Plus (8.0) | Vision Rt, Ltd. | 2026-03-18 |
| K252977 | Halcyon, Ethos Radiotherapy System (5.0) | Varian Medical Systems, Inc. | 2026-01-21 |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | 2026-01-15 |
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | Brainlab SE | 2026-01-14 |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 2026-01-05 |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. | 2025-12-16 |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) | Zap Surgical Systems, Inc. | 2025-11-03 |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. | 2025-10-24 |
| K250911 | MOSkin Radiation Measurement System | Electrogenics Labs, Ltd. | 2025-10-17 |
| K252948 | TrueBeam, TrueBeam STX, Edge and VitalBeam | Varian Medical Systems, Inc. | 2025-10-07 |
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