510(k) K250429
- Device
- DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
- Applicant
- Macromedics BV
- 510(k) number
- K250429
- Product code
- IYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-19
- Date received
- 2025-02-14
- 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
- N
Applicant Contact#
- Contact
- Elizabeth Hajos
- Address
- Oostbaan 670 Moordrecht NL
FDA Registration Numbers#
- 2184007
- 3009754495
- 3010123525
- 3006981798
- 2182762
- 3014113695
- 3016591365
- 3002807314
- 2155
- 8043933
- 2134494
- 3042022819
- 3004637983
- 3009607881
- 3018094310
- 3009302839
- 3025765259
- 3002808157
- 3008317830
- 3008191247
- 1932738
- 3012205931
- 3004608878
- 3004962788
- 9613183
- 3031194398
- 3038289344
- 3006073271
- 3009649442
- 3003793371
- 1000162206
- 3009894282
- 9616684
- 1220477
- 1721113
- 3006946288
- 3014404697
- 3030077501
- 3027080417
- 3015620182
- 3009140718
- 3001722928
- 1055485
- 9614584
- 9614952
- 3013410552
- 3004580128
- 3013012623
- 3009039068
- 3026961165
- 3007615597
- 3015496236
- 9617016
- 3019552217
- 3009394603
- 1038814
- 1000523114
- 3006621300
- 3004753785
- 3007350713
- 3008706707
- 3011716550
- 1123169
- 3007165183
- 3009773332
- 3003418325
- 3016686005
- 3016602874
- 3022973841
- 3003477135
- 3003803149
- 3003768277
- 3010875109
- 2030598
- 3003094912
- 3004363352
- 3022719374
- 3005099803
- 3009077524
- 3007791541
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 |