510(k) K223288
- Device
- Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
- Applicant
- Brainlab AG
- 510(k) number
- K223288
- Product code
- HAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-21
- Date received
- 2022-10-25
- Regulation
- 882.4560
- Classification name
- Neurological Stereotaxic Instrument
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Esther Moreno Garcia
- Address
- Olof-Palme-Str 9 Munich DE 81829 81829
FDA Registration Numbers#
- 3013557562
- 3010047454
- 3009829742
- 3018708317
- 3014596751
- 3004464325
- 2134947
- 3006639944
- 1833506
- 3012322232
- 1836357
- 3005216725
- 3027616024
- 1319639
- 2032112
- 1226544
- 3004188066
- 3003935342
- 3017565094
- 3013302242
- 3008812560
- 1828464
- 3002250546
- 3010123172
- 3019767615
- 1045254
- 2031966
- 3005545216
- 3011713200
- 3010009632
- 3015797559
- 3015112247
- 3003955307
- 1056553
- 3004513872
- 2133772
- 3005075696
- 3011050570
- 3014251656
- 3010120148
- 3004024955
- 3010362364
- 2434444
- 2183570
- 3004753785
- 3012075008
- 1818910
- 1835572
- 3014479313
- 3005180920
- 9610612
- 8030128
- 3002808022
- 3005706667
- 3010197224
- 3011874573
- 1222313
- 3016438694
- 3010041430
- 3016050940
- 3028006458
- 1226188
- 1018470
- 3003418325
- 3008627763
- 2183456
- 9611612
- 2031093
- 3017603615
- 3011724582
- 9611894
- 3003847101
- 3005718816
- 3014170143
- 9617544
- 3004016520
- 9613350
- 2245304
- 2134470
- 3009973336
Source Documents#
Other 510(k) Records For Product Code HAW#
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|---|---|---|---|
| K262214 | Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) | Guangzhou Aimooe Technology Co., Ltd. | 2026-10-15 |
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| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 |
| K253379 | Stealth AXiS Cranial clinical application | Medtronic Navigation, Inc. | 2026-03-26 |
| K231897 | NeuroAlign software | Medivis, Inc. | 2025-10-21 |
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| K250893 | Ball Joint Guide Array (66295) | Bayer Medical Care, Inc. | 2025-09-04 |
| K250505 | EZ-FIDUCIALS | Phasor Health, LLC | 2025-07-09 |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), Cranial | Claronav | 2025-02-05 |
| K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT | Brainlab AG | 2025-01-28 |
| K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025-01-24 |
| K241333 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | 2025-01-17 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 |