Medical device manufacturer
Brainlab AG
Brainlab AG holds 143 FDA 510(k) clearances across 15 product codes. Median elapsed review time is 145 days. openFDA lists 47 recall records naming the company. FDA publishes it under 9 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 143
- Product codes
- 15
- Median review
- 145 days
- Recall records
- 47
How does FDA spell Brainlab AG?
FDA publishes this company under 9 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| BRAINLAB SE | device/registrationlisting | normalised |
| Brainlab | device/510k | normalised |
| Brainlab , Ltd. | device/510k | normalised |
| Brainlab AG | device/510k | normalised |
| Brainlab AG | device/enforcement | normalised |
| Brainlab AG | device/recall | normalised |
| Brainlab Ltd. | device/registrationlisting | normalised |
| Brainlab SE | device/510k | normalised |
Showing 8 of 9.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Brainlab AG file in?
15 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 59 | 184 days | |
| IYE | Accelerator, Linear, Medical | 23 | 67 days | |
| OLO | Orthopedic Stereotaxic Instrument | 21 | 135 days | |
| LLZ | System, Image Processing, Radiological | 14 | 106 days | |
| MUJ | System, Planning, Radiation Therapy Treatment | 11 | 133 days | |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 3 | 160 days | |
| QIH | Automated Radiological Image Processing Software | 3 | 200 days | |
| JAI | Couch, Radiation Therapy, Powered | 2 | 129 days | |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 275 days | |
| JAK | System, X-Ray, Tomography, Computed | 1 | 140 days | |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 308 days | |
| OWB | Interventional Fluoroscopic X-Ray System | 1 | 259 days | |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 1 | 135 days | |
| QQC | Brain Stimulation Programming Planning Software. | 1 | 124 days | |
| SBF | Orthopedic Augmented Reality | 1 | 261 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Brainlab AG had a recall?
openFDA lists 47 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1392-2025Class IIOpen, ClassifiedLLZ
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Z-1292-2023Class IIOpen, ClassifiedOLO
Risk of mechanical instability due to potential manufacturing error of the device
Z-1259-2023Class IIOpen, ClassifiedIYE
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Z-0733-2022Class IIOpen, ClassifiedIYE
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Z-1846-2021Class IITerminatedIYE
Display of potential patient movement might be delayed to the user for high dose treatments.
Showing the 5 most recently initiated of 47.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Brainlab AG cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | IYE | 30 | |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | 70 | |
| K252562 | Spine & Trauma Navigation Instruments | OLO | 29 | |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | OWB | 259 | |
| K243142 | Cranial 4Pi Immobilization | IYE | 266 | |
| 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 | MUJ | 123 | |
| K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | QIH | 200 | |
| K243810 | TraumaCad Neo (1.1) | QIH | 175 | |
| K242569 | Mixed Reality Spine Navigation | SBF | 261 | |
| 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 | HAW | 60 |
Source: openFDA device/510k · retrieved
Where is Brainlab AG registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Brainlab AG files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.