Zeta TMS Navigation System
Device Facts
| Record ID | K261471 |
|---|---|
| Device Name | Zeta TMS Navigation System |
| Applicant | Zeta Surgical, Inc. |
| Product Code | QFF · Neurology |
| Decision Date | Jul 9, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.5805 |
| Device Class | Class 2 |
Indications for Use
The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO. In addition, the product is intended for use with the Apollo TMS Therapy System supplied by MAG & More GmbH (Munich, Germany), only with the following magnetic coils: PMD70-aCool.
Device Story
Stereotaxic image-guided system; assists clinicians in positioning TMS coils relative to patient anatomy. Inputs: 3D neuroimaging scans (CT/MRI). Operation: RealTrack algorithm tracks head movement via native anatomical features; eliminates need for head immobilization or fiducials. System components: navigation cart, software UI, fiducial-attached plate for TMS coil, optional robotic coil holder (7-DOF electromechanical arm). Usage: Clinical environments; operated by trained professionals. Output: Real-time navigation display in three planes (axial, sagittal, coronal) on UI; robotic arm provides spatial positioning of coils. Benefit: Enables precise, computer-assisted TMS coil placement based on patient-specific anatomy.
Clinical Evidence
No clinical testing was required. Substantial equivalence is supported by bench testing, electrical safety (IEC 60601-1, IEC 60601-1-2), and software verification/validation (IEC 62304).
Technological Characteristics
Stereotaxic navigation system; structured light-based infrared 3D camera for registration and tracking. Components: navigation cart, monitor, optional 7-DOF robotic arm. Connectivity: DICOM import for MR/CT. Software: RealTrack algorithm for markerless/pinless tracking. Sterilization: Reusable, non-sterile. Standards: IEC 60601-1, IEC 62304, IEC 60601-1-2, IEC 60601-1-6.
Indications for Use
Indicated for adults (22+ years) requiring accurate positioning of TMS treatment coils relative to target brain locations using 3D neuroimaging data.
Regulatory Classification
Identification
A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
Predicate Devices
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 9, 2026
Zeta Surgical, Inc.
Hieu Le Mau
Chief Operating Officer
280 Summer St.
Floor 7
Boston, Massachusetts 02210
Re: K261471
Trade/Device Name: Zeta TMS Navigation System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: QFF, SGE
Dated: June 9, 2026
Received: June 9, 2026
Dear Hieu Le Mau:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JULIA E.
SLOCOMB -S
Digitally signed by JULIA E.
SLOCOMB -S
Date: 2026.07.09 17:10:35
-04'00'
for Jaime Raben, Ph.D.
Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K261471
Please provide the device trade name(s).
Zeta TMS Navigation System
Please provide your Indications for Use below.
The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging.
The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO. In addition, the product is intended for use with the Apollo TMS Therapy System supplied by MAG & More GmbH (Munich, Germany), only with the following magnetic coils: PMD70-aCool.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Please select the age group(s) for which the device(s) is to be used.
☐ Neonates/Newborns (Birth to < 29 days old)
☐ Infants (29 days old to < 2 years old)
☐ Children (2 years old to < 12 years old)
☐ Adolescents (12 years old to < 22 years old)
☑ Adults (22 years old and greater)
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?
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K261471
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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the Zeta TMS Navigation System is provided below.
# 1. SUBMITTER
Applicant: Zeta Surgical Inc.
280 Summer Street, Floor 7
Boston, MA 02210
Contact: Hieu Le Mau
Chief Operating Officer
Zeta Surgical Inc.
280 Summer Street, Floor 7
Boston, MA 02210
+1 (857) 225-4138
hieu.lemau@zetasurgical.com
# 2. DEVICE
Device Trade Name: Zeta TMS Navigation System
Device Common Name: Neurological Stereotaxic Instrument
Classification Name: Stereotaxic instrument, 21 CFR 882.4560
Regulatory Class: Class II
Product Code: QFF, SGE
# 3. PREDICATE DEVICE
Zeta TMS Navigation System [K251927]
TMS-Cobot TS MV, AXILUM Robotics [K182768]
# 4. DEVICE DESCRIPTION
The Zeta TMS Navigation System is a stereotaxic, image-guided planning and guidance system enabling computer-assisted procedures. The system assists the trained clinical professionals with accurate positioning of the coils of TMS treatment systems relative to patient anatomy by displaying the position of a navigated TMS coil relative to 3D neuroimaging scans. It also has an optional computer-controlled electromechanical arm accessory which can be activated and controlled by the users on the software user interface. The accessory is intended for accurate spatial positioning and orientation of the treatment coils of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging. The system provides navigation in three planes (axial, sagittal, and coronal) and enables the selection of target anatomical points. The underlying RealTrack algorithm allows for real-time tracking of head movement using only the patient's native anatomical features, eliminating the need for rigid head immobilization, body-mounted frames, or facial fiducials. The Zeta TMS Navigation System consists of a navigation cart, a software user interface, and a fiducial-attached plate to be attached to the TMS coil.
510(K) SUMMARY
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# 5. INDICATIONS FOR USE
The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging.
The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO. In addition, the product is intended for use with the Apollo TMS Therapy System supplied by MAG & More GmbH (Munich, Germany), only with the following magnetic coils: PMD70-aCool.
# 6. SUBSTANTIAL EQUIVALENCE
The table below summarizes the substantial equivalence between the Zeta TMS Navigation System (K261471) and its predicate navigation system, Zeta TMS Navigation System (K251927).
| | PREDICATE DEVICE | SUBJECT DEVICE |
| --- | --- | --- |
| 510(K) NUMBER | K251927 | K261471 |
| DEVICE NAME | Zeta TMS Navigation System | Zeta TMS Navigation System |
| CLASSIFICATION REGULATION | 21 CFR 882.4560 | 21 CFR 882.4560 |
| PRODUCT CODE | QFF, SGE | QFF, SGE |
| CLASSIFICATION | Class II | Class II |
| INDICATIONS FOR USE | The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO. | The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO. In addition, the product is intended for use with the Apollo TMS Therapy System supplied by MAG & More GmbH (Munich, Germany), only with the following magnetic coils: PMD70-aCool. |
| INTENDED USER | Trained clinical professionals | Trained clinical professionals |
510(K) SUMMARY
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| | PREDICATE DEVICE | SUBJECT DEVICE |
| --- | --- | --- |
| INTENDED USE ENVIRONMENT | Clinical environments such as medical offices and outpatient facilities, where TMS is administered under the supervision of qualified medical personnel. | Clinical environments such as medical offices and outpatient facilities, where TMS is administered under the supervision of qualified medical personnel. |
| PRESCRIPTION USE | Yes | Yes |
| ANATOMICAL SITE | Head | Head |
| NEURONAVIGATION PRINCIPLE | Anatomy registered to patient via structured light-based infrared 3D camera. Instrument tracking done by infrared 3D camera. | Anatomy registered to patient via structured light-based infrared 3D camera. Instrument tracking done by infrared 3D camera. |
| ACCEPTED IMAGING MODALITIES | 3D DICOM CT, MRI | 3D DICOM CT, MRI |
| MAJOR SYSTEM COMPONENTS | Zeta Cart, Sensor head, Sensor head positioning arm, Monitor, Monitor positioning arm, Tracked TMS coil, Software | Zeta Cart, Sensor head, Sensor head positioning arm, Monitor, Monitor positioning arm, Tracked TMS coil, Software |
| WORKFLOW COMPONENTS | Upload, Segmentation, Planning, Staging/Positioning, Registration, Navigation | Upload, Segmentation, Planning, Staging/Positioning, Registration, Navigation |
| SELECTION OF TARGETS | Targets can be determined on the basis of anatomy and functional areas. | Targets can be determined on the basis of anatomy and functional areas. |
| PLANNING FEATURES | Multiple target point selection, multiple instrument selection | Multiple target point selection, multiple instrument selection |
| 2D VIEWING | Yes: axial, coronal, sagittal slices through configurable cut planes in 3D scene | Yes: axial, coronal, sagittal slices through configurable cut planes in 3D scene |
| 3D VIEWING | Yes: 3D viewing of skin for segmentation and planning | Yes: 3D viewing of skin for segmentation and planning |
| SCANNER INTERFACE | DICOM import of MR/CT images | DICOM import of MR/CT images |
| REGISTRATION FEATURES | Automatic, pinless, and markerless | Automatic, pinless, and markerless |
| COMPATIBLE COILS | Magventure Cool-B65 RO | Magventure Cool-B65 RO, Apollo PMD70-aCool |
| ACCESSORIES | IZI Disposable Passive Blunt Probe | IZI Disposable Passive Blunt Probe, and an optional Robotic Coil Holder |
510(K) SUMMARY
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The table below summarizes the substantial equivalence between the Zeta TMS Navigation System with the robotic coil holder accessory (K261471) and its predicate device, the MagVita TMS Therapy System used in combination with the Axilum Robotics TMS-Cobot TS MV (K182768).
| | PREDICATE DEVICE | SUBJECT DEVICE |
| --- | --- | --- |
| 510(K) NUMBER | K182768 | K261471 |
| DEVICE NAME | MagVita TMS Therapy System using Axilum Robotics TMS-Cobot TS MV | Zeta TMS Navigation System using Zeta Robotic Coil Holder |
| PRODUCT CODE | QFF | QFF, SGE |
| CLASSIFICATION | Class II | Class II |
| INTENDED USE OF ELECTROMECHANICAL ARM | Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System. | Robotic Coil Holder consists of a computer controlled electromechanical arm indicated for spatial positioning and orientation of compatible TMS treatment coils. |
| COIL HOLDER | Active electromechanical arm | Active electromechanical arm |
| DEGREES OF FREEDOM | 6 | 7 |
## 7. PERFORMANCE DATA
### 7.1. Biocompatibility Testing
There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.
### 7.2. Electrical safety and electromagnetic compatibility (EMC)
The subject device was tested in accordance with the following standards:
- IEC 60601-1:2005 (Ed. 3) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance including US deviations, except Clause 11.7 regarding biocompatibility. The Zeta navigation cart passed all tests.
- IEC 62304:2006+ Amd 1:2015, Medical device software - Software life cycle processes. The Zeta navigation cart passed all tests.
- IEC 60601-1-2:2014+A1:2021, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests. The Zeta navigation cart passed all tests.
510(K) SUMMARY
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K261471
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- IEC 60601-1-6 (Ed. 3.2 2020-07), Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. The Zeta navigation cart passed all tests.
- IEC 60601-1-2:2020 (Ed. 4.1), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests. The optional robot cart accessory passed all tests.
- IEC TS 60601-4-2:2024 (Ed. 1.0), Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems. The optional robot cart accessory passed all tests.
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601 1:2005/AMD2:2020 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance. The optional robot cart accessory passed all tests.
### 7.3. Software Verification and Validation Testing
Software verification and validation testing was conducted, and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Cybersecurity documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
### 7.4. Sterilization, Cleaning, and Shelf Life
The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling. Shelf-life is not applicable due to the low likelihood of time-dependent product degradation.
### 7.5. Bench Testing
Bench testing was conducted to demonstrate substantial equivalence. The testing provides objective evidence that the device meets all Design Input requirements, maintains basic safety and essential performance under clinically relevant conditions, and complies with the latest regulatory standards.
### 7.6. Clinical Testing
No clinical testing was required for the subject device.
### 8. CONCLUSION
The results of testing described above demonstrate that the Zeta TMS Navigation System and the optional Robotic Coil Holder accessory, is as safe and effective as the predicate device and supports a determination of substantial equivalence.
510(K) SUMMARY
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