510(k) K152321
- Device
- KVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization Device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracrani
- Applicant
- QFIX
- 510(k) number
- K152321
- Product code
- IYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-04
- Date received
- 2015-08-17
- 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
- NADIA SOOKDEO HARHEN
- Address
- 440 Church Rd. Avondale PA US 19311 19311
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#
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