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
FDA 510(k) clearance K243698 · decided 2025-01-28
Clearance details
- K-number
- K243698
- Device name
- 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
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2024-11-29
- Decision date
- 2025-01-28
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Leksell® Vantage Stereotactic System (K261932) | Elekta Solutions AB | 2026-08-05 |
| Zeta Navigation System (K253663) | Zeta Surgical, Inc. | 2026-05-01 |
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| NeuroAlign software (K231897) | Medivis, Inc. | 2025-10-21 |
| SOLOPASS 2.0 System (K251317) | Intravent Medical Partners | 2025-09-05 |
| Ball Joint Guide Array (66295) (K250893) | Bayer Medical Care, Inc. | 2025-09-04 |
| EZ-FIDUCIALS (K250505) | Phasor Health, LLC | 2025-07-09 |
| Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| Navient Image Guide Navigation System (955-NC-NC), Cranial (K241327) | Claronav | 2025-02-05 |
| ClearPoint System (Software Version 3.0) (K243657) | ClearPoint Neuro, Inc. | 2025-01-24 |
| Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333) | Koh Young Technology, Inc. | 2025-01-17 |
| FLASH EVD System (10-0002) (K242480) | 7D Surgical ULC | 2024-12-27 |
Recalls involving this device
No recalls on record reference this clearance.