Neurology · 510(k) · 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Brainlab AG. Cleared by FDA on 21 July 2023 under submission K223288, product code HAW (neurological stereotaxic instrument). What FDA's record says, in FDA's words.
Device record · K223288
- Device. Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIDEVICE
- Company. Brainlab AG (DE)COMPANY
- Decision. 21 July 2023, 510(k), substantially equivalent (traditional review); received 25 October 2022DECISION
- Panel. NeurologyPANEL
- Product code. HAW, Neurological Stereotaxic InstrumentCODE
- Regulation. 21 CFR 882.4560, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Cranial Navigation The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image space on patient image data being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including: • Cranial Resection • Resection of tumors and other lesions • Resection of skull-base tumor or other lesions • AVM Resection • Craniofacial Procedures (including cranial and midfacial bones) • Tumor Resection • Bone Tumor Defect Reconstruction • Bone Trauma Defect Reconstruction • Bone Congenital Defect Reconstructions • Orbital cavity reconstruction procedures • Removal of foreign objects Cranial EM System Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as: • Cranial Resection o Resection of tumors and other lesions o Resection of skull-base tumor or other lesions • Intracranial catheter placement
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI, radiographs (X-ray), ultrasound
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 42,962 reports filed against devices carrying product code HAW. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01386
Medtronic received information regarding a Navigation system being used outside of a procedure. It was reported that an inaccuracy was experienced while working with 2 different instruments in the same case. The application team found that the issue was with the end user (human issue). After that they verified the accuracy using demo sample. It was reported that all instruments were accurate and that the issue was with the end user. The amount of the inaccuracy was 10 mm, but it was not […]
30 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01389
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that the system had wear on the main power cable to the system. The grey coating was changing to white. There were no tears and no cable showing. There was no patient involvement.
30 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01390
30 September 2026 · Malfunction · brand not stated · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01391
29 September 2026 · Malfunction · StealthStation¿ S8 system · MEDTRONIC NAVIGATION, INC. · report 1723170-2026-01382
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code HAW, in Neurology, from Brainlab AG, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.