FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
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
K Number: K243698
·
Decision Jan 28, 2025
Classifications
1
FEI Numbers
246
Registration Numbers
246
Same Product Code
417
Applicant Total
47
Review Days
60
Basic Information
- 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
- K Number
- K243698
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainlab AG
- Date Received
- November 29, 2024
- Decision Date
- January 28, 2025
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Brainlab AG
| K Number | Device Name | ||
|---|---|---|---|
| K243142 | Cranial 4Pi Immobilization | Jun 23, 2025 | Substantially Equivalent |
| K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Jun 17, 2025 | Substantially Equivalent |
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| K242569 | Mixed Reality Spine Navigation | May 16, 2025 | Substantially Equivalent |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | Jul 24, 2024 | Substantially Equivalent |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | May 23, 2024 | Substantially Equivalent |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | May 21, 2024 | Substantially Equivalent |
| K234047 | Automatic Registration | Mar 20, 2024 | Substantially Equivalent |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Sep 9, 2023 | Substantially Equivalent |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Aug 2, 2023 | Substantially Equivalent |