DORO LUCENT® iXI and iMRI Headrest System

K191740 · Pro Med Instruments GmbH · HBL · Feb 21, 2020 · Neurology

Device Facts

• Record ID: K191740
• Device Name: DORO LUCENT® iXI and iMRI Headrest System
• Applicant: Pro Med Instruments GmbH
• Product Code: HBL · Neurology
• Decision Date: Feb 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used. The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used. The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

Device Story

Mechanical support system for cranial stabilization during neurosurgery and intra-operative imaging (MR, CT, X-Ray, Angiography). Components include skull clamp, skull pins, parallelogram adaptor, and headplate. Used in OR; operated by surgical staff. Provides rigid three-point fixation or noninvasive positioning. Interfaces with OR tables via specific adaptors and supports accessories like navigation adaptors and retractors. Enables stable patient positioning while maintaining imaging compatibility. Benefits include secure stabilization and seamless integration with intra-operative imaging workflows.

Clinical Evidence

Bench testing only. Testing included static load verification, MR-compatibility, CT/Angio-compatibility, X-ray compatibility, torque resistance for rocker arms, mechanical stability (scratch test) for skull pins, sterility, and biocompatibility. All tests passed.

Technological Characteristics

Mechanical support system; materials include polymers, glass, composites, and metal coating. Features three-point fixation or noninvasive headplate. MR conditional (≤ 3T). Connectivity via Quick-Rail interface and M16/M18 mechanical attachments to OR tables. Nonsterile delivery; skull pins sterilized via gamma radiation (SAL 10-6).

Indications for Use

Indicated for patients undergoing cranial and spine surgery requiring rigid skeletal fixation or noninvasive head positioning/stabilization during intra-operative imaging.

Regulatory Classification

Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Predicate Devices

• DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS (K063494)

Submission Summary (Full Text)

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Pro Med Instruments GmbH Sandra Untenberger Regulatory Affairs Manager Boetzinger Str. 38 Freiburg, 79111 DE

Re: K191740

Trade/Device Name: DORO LUCENT iXI and iMRI Headrest System Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: January 17, 2020 Received: January 22, 2020

Dear Sandra Untenberger:

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191740

Device Name

DORO LUCENT® iXI and iMRI Headrest System

Indications for Use (Describe)

The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.

The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.

The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "pmi" in a stylized font. The "p" is lowercase and has a curved shape. The "m" and "i" are also lowercase and connected. Above the "mi" is a blue circle. To the right of the "p" is the text "pro med instruments" in a smaller font.

| DATE OF APPLICATION: | 14.05.2019 |
|----------------------|-----------------------------|
| APPLICANT: | pro med instruments GmbH |
| | Bötzinger Straße 38 |
| | 79111 Freiburg im Breisgau |
| | Germany |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-Mail: [e-mail] |

# CONTACT PERSON:

Name: Sandra Untenberger Position: Regulatory Affairs Tel.: [phone] E-Mail: [e-mail]

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Image /page/4/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features a stylized letter 'p' connected to the letters 'mi'. To the right of the 'mi' is the text 'pro med instruments' in a smaller, sans-serif font. The overall design is modern and clean.

### 1 Device Name

| Trade Name: | DORO LUCENT® iXI and iMRI Headrest System |
|-----------------------------|-------------------------------------------|
| Common Name: | Neurosurgical Head Holder (Skull Clamp) |
| Device Classification Name: | Holder, head, neurosurgical (Skull Clamp) |

## Classification / Product Code 2

DORO LUCENT® iXI and iMRI Headrest System can be classified according to following device name and product code:

| Device | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review<br>Panel | Product<br>Code | Regulation<br>Number | Device<br>Classification |
|-------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Holder, head,<br>neurosurgical<br>(Skull Clamp) | Neurosurgical<br>head holder<br>(Skull Clamp) | Neurology | Neurology | HBL | 882.44602 | 2 |

### Predicate Device / Reference Device က

| Device | Predicate Device | 510(k)<br>Number | 510(k) Holder |
|-------------------------------------------------|-------------------------------------------------------------------------------|------------------|--------------------------|
| DORO LUCENT® iXI<br>and iMRI Headrest<br>System | DORO RADIOLUCENT HEADREST<br>SYSTEM ( ALSO MRI-<br>COMPATIBLE) AND COMPONENTS | K063494 | pro med instruments GmbH |

## ব Device Description

The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.

The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.

Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.

These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:

- . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
- 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
- . 4003.500 DORO LUCENT® iXI Headrest System

By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.

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Image /page/5/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "pmi" in a stylized font. The letters "pro med instruments" are written in a smaller font to the right of the letters "pmi".

#### 5 Intended Use

The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.

The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.

The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.

#### Technological Characteristics 6

The Technological Characteristics of DORO LUCENT® iXI and iMRI Headrest System are the same as the Technological Characteristics of the predicate device.

| | pro med instruments GmbH<br>--<br>DORO LUCENT® iXI and iMRI Headrest<br>System<br>(New Device) | pro med instruments GmbH<br>--<br>DORO RADIOLUCENT HEADREST SYSTEM<br>(ALSO MRI-COMPATIBLE) AND<br>COMPONENTS<br>(Predicate Device) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DORO LUCENT® iXI and iMRI Headrest<br>System | DORO RADIOLUCENT HEADREST SYSTEM<br>(ALSO MRI-COMPATIBLE) AND<br>COMPONENTS |
| Regulation<br>Number | 882.4460 | 882.4460 |
| Class | 2 | 2 |
| Code | HBL | HBL |
| 510(k)<br>number | --- | K063494 |
| | pro med instruments GmbH | pro med instruments GmbH |
| | DORO LUCENT® iXI and iMRI Headrest<br>System<br>(New Device) | DORO RADIOLUCENT HEADREST SYSTEM<br>( ALSO MRI-COMPATIBLE) AND<br>COMPONENTS<br>(Predicate Device) |
| Indication<br>for use | The DORO LUCENT radiolucent/MRI<br>Compatible Headrest System with Skull Pins<br>are components of a mechanical support<br>system, which is used in cranial and spine<br>surgery when rigid skeletal fixation is required<br>for cranial stabilization and when intra-<br>operative imaging is used.<br>The DORO LUCENT radiolucent/MRI<br>Compatible Headrest System with noninvasive<br>head positioning or noninvasive cranial<br>stabilization device are components of a<br>mechanical support system, which is used in<br>cranial and spine surgery when noninvasive<br>head positioning or noninvasive cranial<br>stabilization is required and when intra-<br>operative imaging is used.<br>The DORO LUCENT Headrest System provides<br>an interface for accessories like retractor<br>systems, navigation adaptors or other items. | The Radiolucent/ MRI Compatible Skull<br>Clamp Headrest System with Skull Pins<br>The DORO® Radiolucent/ MRI Compatible<br>Skull Clamp Headrest System with Skull Pins<br>are components of a mechanical support<br>system which is used in head and neck<br>surgery when rigid skeletal fixation is required<br>for cranial stabilization and when<br>intra-operative CT or MR Imaging is used.<br>The Radiolucent/ MRI Compatible<br>Horseshoe Headrest System<br>The DORO® Radiolucent/ MRI Compatible<br>Horseshoe Headrest System are components<br>of a mechanical support system which is used<br>in head and neck surgery when non-invasive<br>head support is required and when intra-<br>operative CT or MR Imaging is used.<br>The Radiolucent/ MRI Compatible Halo<br>System<br>The DORO® Radiolucent/ MRI Compatible<br>Halo System is a system of radiolucent halo<br>rings of varying size and styles that may be<br>used in neurosurgical applications as an arm<br>rest during head and neck surgery when<br>intra-operative CT or MR Imaging is required. |
| Principles of<br>operation | Mechanical support system | Mechanical support system |
| Method of<br>cranial<br>stabilization | Rigid skeletal fixation or noninvasive<br>stabilization | Rigid skeletal fixation or secured noninvasive<br>stabilization |
| Method of<br>cranial<br>fixation | Three-point fixation in prone, supine or lateral<br>position | Three-point fixation in prone, supine, lateral<br>or sitting position |
| Method of<br>noninvasive<br>stabilization | Pad for prone or supine positioning | Non-invasive gel pad for prone or supine<br>positioning |
| Intraoperati<br>ve imaging | MR-, CT-, X-Ray- and Angiography-Imaging | MR-, CT- and X-Ray Imaging |
| reprocessing | Manual cleaning and disinfection between<br>uses;<br>single-use pins | Manual cleaning and disinfection between<br>uses;<br>single-use pins |

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Image /page/6/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "p", "m", and "i". The letters are stylized and connected to each other. The words "pro med instruments" are written in a smaller font to the right of the letters.

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Image /page/7/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and features the letters "pmi" in a stylized font. The words "pro med instruments" are written in a smaller font to the right of the letters "pmi".

| | pro med instruments GmbH<br>--<br>DORO LUCENT® iXI and iMRI<br>Headrest System<br>(New Device) | pro med instruments GmbH<br>--<br>DORO RADIOLUCENT HEADREST<br>SYSTEM ( ALSO MRI-<br>COMPATIBLE) AND<br>COMPONENTS<br>(Predicate Device) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DORO® Skull Clamp radiolucent<br>for DORO LUCENT®<br>Parallelogram Adaptors | DORO® Skull Clamp Radiolucent |
| Sterility | Nonsterile | Nonsterile |
| Type of head fixation | 3 point fixation | 3 point fixation |
| Shape/ general design | U-shape | U-shape |
| Adjustment for various head<br>sizes | Extension assembly is adjustable | Extension assembly is adjustable |
| Clamping force | Max. 360 N/ 80 lbs | Max. 360 N/ 80 lbs |
| Load range | Max. 12.5 kg/ 27.5 lbs | Max. 12.5 kg/ 27.5 lbs |
| Interface for accessories | Quick-Rail® | Quick-Rail® |
| Imaging modality | radiolucent,<br>MR conditional (≤ 3T) | radiolucent,<br>MR safe |
| Patient contact components/<br>materials | None | None |
| Materials: | polymers, glass, composites, metal<br>coating | polymers, composites |
| | | |
| | DORO LUCENT® Headplate | DORO® Adult Horsehoe<br>Headrest Radiolucent without<br>Extension bar<br>combined with<br>DORO® Horseshoe Gel Pads<br>(left & right) |
| Sterility | Nonsterile | Nonsterile |
| Type of head fixation | Noninvasive | Noninvasive |
| Shape/ general design | Headplate base plate with foam pad | Horseshoe shaped base with gel-<br>pads |
| Load range | Max. 12.5 kg/ 27.5 lbs | Max. 12.5 kg/ 27.5 lbs |
| Imaging modality | radiolucent,<br>MR conditional (≤ 3T) | radiolucent,<br>MR safe |
| Materials: | Polymers, composites | Polymers |
| | | |
| | DORO LUCENT® Disposable<br>Skull Pins, Adult, sterile | DORO® Radiolucent Disposable<br>Skull Pins, Ceramic, Adult |
| Sterility | SAL 10-6 by gamma radiation | SAL 10-6 by ethylene oxide |
| Frequency of use | Single use | Single use |
| Packaging | Sterile blister pack | Sterile blister pack |
| Shape/ general design | Pin tip injected with plastic | Pin tip injected with plastic |
| Imaging modality | radiolucent,<br>MR conditional (≤ 3T, SAR≤<br>4W/kg) | radiolucent,<br>MR safe |
| Materials: | Polymers, composites | Polymers |
| | DORO LUCENT® Parallelogram<br>Adaptor Trumpf for Siemens<br>Aera/Skyra MRI systems | DORO® Swivel Adaptor<br>Radiolucent<br>combined with<br>DORO® Transitional Member<br>Radiolucent (short and/or long) |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the Skull<br>Clamp on one side and the Transfer<br>Board on the other, which is fixed<br>to the OR-Table. The joint system<br>in the parallelogram design<br>combined with the joint for height<br>adjustment, allows for the<br>positioning adjustment in all<br>degrees of freedom. | Different rods with interfaces to the<br>Skull Clamp on one side and the<br>OR-Table on the other side. The<br>rods are connected with screws,<br>wherein the positioning adjustment<br>can be realized. The Swivel Adaptor<br>is rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-<br>direction<br>Linear axis (y): Lateral<br>Linear axis (z): upwards/<br>downwards<br>Rotation axes: around x-, y- and z-<br>axis | Linear axis (x): cranial/caudal-<br>direction<br>Linear axis (y): Lateral<br>Linear axis (z): upwards/<br>downwards<br>Rotation axes: around x-, y- and z-<br>axis |
| Load range | 12.5 kg/ 27.5 lbs | 12.5 kg/ 27.5 lbs |
| Interface OR-table | 6 screws (M8) for attaching the<br>adaptor on the Transfer Board<br>(Trumpf OR-Table) | Starburst with screw (M16) |
| Interface Skull Clamp/ Head<br>plate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,<br>MR conditional (≤ 3T) | radiolucent,<br>MR safe |
| Materials: | Polymers, composites, metal | Polymers, composite |
| | | |
| | DORO LUCENT® iMRI<br>Parallelogram Adaptor Maquet | DORO® Swivel Adaptor<br>Radiolucent<br>combined with<br>DORO® Transitional Member<br>Radiolucent (short and/or long) |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the Skull<br>Clamp on one side and the Transfer<br>Board on the other, which is fixed<br>to the OR-Table. The joint system<br>in the parallelogram design<br>combined with the joint for height<br>adjustment, allows for the<br>positioning adjustment in all<br>degrees of freedom. | Different rods with interfaces to the<br>Skull Clamp on one side and the<br>OR-Table on the other side. The<br>rods are connected with screws,<br>wherein the positioning adjustment<br>can be realized. The Swivel Adaptor<br>is rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-<br>direction<br>Linear axis (y): Lateral<br>Linear axis (z): upwards/<br>downwards<br>Rotation axes: around x-, y- and z-<br>axis | Linear axis (x): cranial/caudal-<br>direction<br>Linear axis (y): Lateral<br>Linear axis (z): upwards/<br>downwards<br>Rotation axes: around x-, y- and z-<br>axis |
| Load range | 12.5 kg/ 27.5 lbs | 12.5 kg/ 27.5 lbs |
| Interface OR-table | 4 screws (M18) for attaching the<br>adaptor on the Transfer Board<br>(Maquet OR-Table) | Starburst with screw (M16) |
| Interface Skull Clamp/ Head<br>plate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,<br>MR safe | radiolucent,<br>MR safe |
| Materials: | Polymers, composites | Polymers, composites |
| | DORO LUCENT® IXI<br>Parallelogram Adaptor Maquet | DORO® Swivel Adaptor<br>Radiolucent<br>combined with<br>DORO® Transitional Member<br>Radiolucent (short and/or long) |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the Skull<br>Clamp on one side and the Transfer<br>Board on the other, which is fixed<br>to the OR-Table. The joint system<br>in the parallelogram design<br>combined with the joint for height<br>adjustment, allows for the<br>positioning adjustment in alldegrees of freedom. | Different rods with interfaces to the<br>Skull Clamp on one side and the<br>OR-Table on the other side. The<br>rods are connected with screws,<br>wherein the positioning adjustment<br>can be realized. The Swivel Adaptor<br>is rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-<br>direction<br>Linear axis (y): Lateral<br>Linear axis (z): upwards/<br>downwards<br>Rotation axes: around x-, y- and z-<br>axis | Linear axis (x): cranial/caudal-<br>direction<br>Linear axis (y): Lateral<br>Linear axis (z): upwards/<br>downwards<br>Rotation axes: around x-, y- and z-<br>axis |
| Load range | 11 kg/ 24.25 lbs | 12.5 kg/ 27.5 lbs |
| Interface OR-table | Slim plate with lateral rails to insert<br>the adaptor in the Transfer Board<br>(Maquet OR-Table) and clamping<br>mechanism to protect pulling out<br>the adaptor. | Starburst with screw (M16) |
| Interface Skull Clamp/ Head<br>plate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,<br>MR safe | radiolucent,<br>MR safe |
| Materials | Polymers, composites | Polymers, composites |

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Image /page/8/Picture/2 description: The image shows the logo for "pro med instruments". The logo is primarily blue. The letters "pmi" are stacked on top of each other on the left side of the logo, with the words "pro med instruments" written in a smaller font to the right of the letters.

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Image /page/9/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features a stylized lowercase 'p' that transitions into the letters 'mi'. To the right of the 'mi' is the text 'pro med instruments' in a smaller font size.

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Image /page/10/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features the letters 'pmi' in a stylized font. The 'p' is lowercase and has a curved shape, while the 'm' and 'i' are connected and slightly smaller, positioned above the words 'pro med instruments' in a smaller, sans-serif font. A blue circle is positioned above the 'i'.

# 6.1 Summary of Technological Characteristics

The above listed Technologica…