510(k) K132908
- Device
- TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
- Applicant
- MEDTEC, INC.
- 510(k) number
- K132908
- Product code
- IYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-03-04
- Date received
- 2013-09-17
- 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
- AMANDA STAHLE
- Address
- 1401 8th St. SE Orange City IA US 51041 51041
FDA Registration Numbers#
- 3013410552
- 3003768277
- 3015232217
- 1721113
- 1722661
- 3015621321
- 3015620182
- 3025765259
- 2182762
- 3007791541
- 3009773332
- 3038289344
- 3011716550
- 3003094912
- 1055485
- 3003477135
- 3010625741
- 3009394603
- 3006894636
- 9710332
- 3014428919
- 3007165183
- 3012039133
- 3013012623
- 3030077501
- 2939248
- 3033484057
- 1000162206
- 2134494
- 3009302839
- 3004637983
- 3004962788
- 3006621300
- 2183744
- 9681124
- 1219183
- 3014404697
- 3001722928
- 1038814
- 3026961165
- 3009649442
- 3015119628
- 1450662
- 3009039068
- 3027080417
- 3006073271
- 3003793371
- 1932738
- 2030598
- 1647149
- 3009607881
- 1526854
- 3015548663
- 2247992
- 1720929
- 3006405073
- 3003418325
- 3022719374
- 1123169
- 3012205931
- 3004832819
- 3004580128
- 3010701021
- 2436865
- 9616684
- 3010123525
- 2916710
- 2431392
- 3002807314
- 3010875109
- 3004753785
- 3007615597
- 3009140718
- 3006946288
- 3014113695
- 3012631246
- 9617016
- 3008317830
- 3007037519
- 3042022819
Source Documents#
Other 510(k) Records For Product Code IYE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252174 | AquaCast Mask | Blessing Cathay Corporation | 2025-09-03 |
| K243142 | Cranial 4Pi Immobilization | Brainlab AG | 2025-06-23 |
Legacy Summary#
summary
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