(131 days)
LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.
LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.
The LUMINOS Q.namix T is an under-table fluoroscopy system and the LUMINOS Q.namix R is an over-table fluoroscopy system. Both systems are multifunctional, general R/F systems, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. They are designed as modular systems with components such as main fluoro table including fixed fluoroscopy detector and X-ray tube, a ceiling suspension with X-ray tube, Bucky wall stand, X-ray generator, monitors, a bucky tray in the table as well as portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
This FDA 510(k) clearance letter and summary discuss the LUMINOS Q.namix T and LUMINOS Q.namix R X-ray systems. The provided documentation does not include specific acceptance criteria (e.g., numerical thresholds for image quality, diagnostic accuracy, or performance metrics) in the same way an AI/ML device often would. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to recognized standards.
The study presented focuses primarily on image quality evaluation for the new detectors (X.fluoro and X.wi-D24) for diagnostic acceptability, rather than establishing acceptance criteria for the entire system's overall performance.
Here's an attempt to extract and present the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria for the overall device performance are not stated in the provided 510(k) summary, this section will reflect the available qualitative performance assessment for the new detectors. The primary "acceptance criterion" implied for the overall device is substantial equivalence to predicate devices and acceptability for diagnostic use.
| Feature/Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (LUMINOS Q.namix T/R with new detectors) |
|---|---|---|
| Overall Device Equivalence | Substantially equivalent to predicate devices (Luminos Agile Max, Luminos dRF Max) in indications for use, design, material, functionality, technology, and energy source. | Systems are comparable and substantially equivalent to predicate devices. Test results show comparability. |
| New Detector Image Quality (X.fluoro, X.wi-D24) | Acceptable for diagnostic use in radiography & fluoroscopy. | Evaluated images and fluorography studies from different body regions were qualified for proper diagnosis by a US board-certified radiologist and by expert evaluations. |
| Compliance with Standards | Compliance with relevant medical electrical safety, performance, and software standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, DICOM). | The LUMINOS Q.namix T/LUMINOS Q.namix R systems were tested and comply with the listed voluntary standards. |
| Risk Management | Application of risk management process (per ISO 14971). | Risk Analysis was applied. |
| Software Life Cycle | Application of software life cycle processes (per IEC 62304). | IEC 62304 (Medical device software - Software life cycle processes) was applied. |
| Usability | Compliance with usability engineering standards (per IEC 60601-1-6, IEC 62366-1). | IEC 60601-1-6 and IEC 62366-1 were applied. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: "expert evaluations" for the new detectors X.fluoro and X.wi-D24.
- Sample Size: The exact number of images or fluorography studies evaluated is not specified. The document mentions "multiple images and fluorography studies from different body regions" for the US board-certified radiologist's evaluation.
- Data Provenance:
- Countries of Origin: Germany (University Hospital Augsburg, Klinikum rechts der Isar Munich, Herz-Jesu-Krankenhaus Münster/Hiltrup) and Belgium (ZAS Jan Palfijn Hospital of Merksem).
- Retrospective or Prospective: Not explicitly stated, but clinical image quality evaluations often involve prospective data collection or a mix with retrospective cases. Given they are evaluating "new detectors" and "clinical image quality evaluation", it implies real or simulated clinical scenarios.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts:
- Initial Evaluations: Multiple "expert evaluations" (implies more than one) were conducted across the listed hospitals. The exact number of individual experts is not specified.
- Specific Evaluation: One "US board-certified radiologist" performed a dedicated clinical image quality evaluation.
- Qualifications of Experts:
- For the general "expert evaluations": Not specified beyond being "experts."
- For the specific evaluation: "US board-certified radiologist." No mention of years of experience is provided.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1 consensus voting) for establishing ground truth or evaluating the image quality. The evaluations appear to be individual or group assessments leading to a conclusion of "acceptability for diagnostic use."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? The document does not describe a formal MRMC comparative effectiveness study designed to quantify the improvement of human readers with AI vs. without AI assistance.
- Effect Size of Human Reader Improvement: Therefore, no effect size is reported.
- Note: While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the study described is an evaluation of the detectors' image quality and the overall system's substantial equivalence, not the clinical impact of these specific AI features on human reader performance.
6. Standalone Performance Study (Algorithm Only)
- The document primarily describes an evaluation of the new detectors within the LUMINOS Q.namix T/R systems and the overall system's substantial equivalence.
- While the device includes "AI-based Auto Cropping" and "AI based Automatic collimation," the document does not report on a standalone performance study specifically for these AI algorithms in isolation from the human-in-the-loop system. The AI features are listed as technological characteristics that contribute to the device's overall updated design.
7. Type of Ground Truth Used
For the detector image quality evaluation, the ground truth was based on expert assessment ("qualified for proper diagnosis"). This falls under expert consensus or expert judgment regarding diagnostic acceptability.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set for any AI components. The focus of this 510(k) summary is on substantiating equivalence and safety/effectiveness of the entire X-ray system, not on the development of individual AI algorithms within it.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set, the method for establishing its ground truth is not mentioned in the document.
FDA 510(k) Clearance Letter - LUMINOS Q.namix T and R
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 14, 2025
Siemens Medical Solutions
℅ Camila Rodriguez Valentin
Regulatory Affairs Professional
40 Liberty Boulevard
MALVERN, PA 19355
Re: K250660
Trade/Device Name: LUMINOS Q.namix T
LUMINOS Q.namix R
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, JAA
Dated: March 5, 2025
Received: June 12, 2025
Dear Camila Rodriguez Valentin:
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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K250660 - Camila Rodriguez Valentin Page 2
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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 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-
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K250660 - Camila Rodriguez Valentin Page 3
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,
Lu Jiang
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250660
Device Name: LUMINOS Q.namix T
LUMINOS Q.namix R
Indications for Use (Describe)
LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.
LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Siemens Medical Solutions USA, Inc.
Page 1 of 13
Tel.: +1-888-826-9702
usa.siemens.com/healthineers
40 Liberty Boulevard
Malvern, PA 19355
USA
510(k) Summary
- Trade Names: LUMINOS Q.namix T
- LUMINOS Q.namix R
510(k) Number: K250660
Company: Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Date Prepared: July 13, 2025
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR § 807.92.
1. General Information:
Importer / Distributor:
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number: 2240869
Location of Manufacturing Site:
Siemens Healthineers AG
Siemensstr. 1
91301 Forchheim, Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Camila Rodriguez Valentin
Sr. Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, US
camila.rodriguezvalentin@siemens-healthineers.com
Alternate Contact Person:
Martin Rajchel
Senior Regulatory Affairs Manager
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, US
martin.rajchel@siemens-healthineers.com
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3. Subject Devices Names and Classification:
Trade Names: LUMINOS Q.namix T
LUMINOS Q.namix R
Classification Name: Image-intensified fluoroscopic x-ray system
Classification Panel: Radiology
Classification Regulation: 21 CFR §892.1650
Device Class: II
Product Code: OWB, JAA
4. Legally Marketed Predicate Devices:
Trade Names: Luminos Agile Max
Luminos dRF Max
510(k) Number: K173639
Classification Name: Image-intensified fluoroscopic x-ray system
Classification Panel: Radiology
Classification Regulation: 21 CFR §892.1650
Device Class: II
Product Code: OWB, JAA
Reference Device:
Trade Names: YSIO X.pree
510(k) Number: K233543
Classification Name: Stationary x-ray system
Classification Panel: Radiology
Classification Regulation: 21 CFR §892.1680
Device Class: II
Product Code: KPR
5. Device Descriptions
The LUMINOS Q.namix T is an under-table fluoroscopy system and the LUMINOS Q.namix R is an over-table fluoroscopy system. Both systems are multifunctional, general R/F systems, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. They are designed as modular systems with components such as main fluoro table including fixed fluoroscopy detector and X-ray tube, a ceiling suspension with X-ray tube, Bucky wall stand, X-ray generator, monitors, a bucky tray in the table as well as portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.
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6. Indication for Use:
LUMINOS Q.namix T and LUMINOS Q.namix R are a devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics.
LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.
7. Technological Characteristics and Substantial Equivalence
The LUMINOS Q.namix T/ LUMINOS Q.namix R systems are comparable in indications for use, design, material, functionality, technology, and energy source and are substantially equivalent to the commercially available LUMINOS Agile Max (under-table fluoroscopy system) and LUMINOS dRF Max (over- table fluoroscopy system). The subject devices do not alter the fundamental scientific technology compared to the predicate devices. The subject devices use the same or similar components cleared with predicate systems. Many components of the subject devices have the same technological characteristics as those from the predicate devices. Testing and validation have been successfully completed, and test results show that the subject devices LUMINOS Q.namix T and LUMINOS Q.namix R, with all of their components, are comparable and, therefore, substantially equivalent to the predicate devices.
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Table 7-1. Comparison of the Subject Device (LUMINOS Q.namix T) to the Predicate Device (Luminos Agile Max K173639)
| Feature | Predicate device Luminos Agile Max | Subject device LUMINOS Q.namix T | Comment |
|---|---|---|---|
| Regulation Description | System, x-ray, fluoroscopic, image-intensified, Solid State X-ray imager | System, x-ray, fluoroscopic, image-intensified, Solid State X-ray imager | Same |
| Regulation Number | 892.1650 | 892.1650 | Same |
| Classification Product Code | JAA, OWB | JAA, OWB | Same |
| Indications for use | Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos Agile Max is not for mammography examinations. | LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations. | Similar |
| X-Ray Generator | Polydoros F80 65/80 kW | Polydoros RFX 65/80 kW | Changed, new State of the Art Generator |
| X-Ray tube | OPTITOP 150/40/80/HC-100 | OPTITOP 150/40/80/HC-100 | Same |
| X-ray techniques | Radiography, Pulsed fluoroscopy, DSA and series exposure | Radiography, Pulsed fluoroscopy and series exposure | Changed, DSA function is not available at LUMINOS |
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| Feature | Predicate device Luminos Agile Max | Subject device LUMINOS Q.namix T | Comment |
|---|---|---|---|
| Q.namix T | |||
| Collimator | Digital Multileaf Collimator N | Digital Multileaf Collimator RFU | Changed, new collimator |
| Air kerma | Kerma X | Kerma X | Same |
| CARE | Combined Applications to Reduce Exposure | Combined Applications to Reduce Exposure | Same |
| Touch user interface on tube suspension | touchscreen in portrait format | touchscreen in landscape format | Changed, same touch user interface as for reference device YSIO X.pree is used |
| Controls at Digital Imaging Tower (DIT) Digital Imaging | hardware buttons | Two touch user interfaces at left and right side, replacing most of the hardware buttons | Changed, new touch user interface |
| Fluoro Detector in DIT | Trixel pixium 4343F-4 "Max Dynamic" | Trixel pixium 4343F-5 "X.fluoro" | Changed, new version of the Fluoro detector |
| Fixed detector for wall stand | Trixell pixium 4343RCE "Max Static" | Trixell pixium 4343RCE "Max Static" | Same |
| Large mobile detectors | Trixell pixium 3543EZh „MAX wi-D" | Trixell pixium 3543EZh „MAX wi-D" | Same |
| N/A | Trixell pixium 3543EZ3 "X.wi-D 35" | New, Same as for reference device YSIO X.pree. | |
| N/A | Trixell pixium 4343EZ3 "X.wi-D 43" | New, Same as for reference device YSIO X.pree. | |
| Small mobile detector | Trixell pixium 2430EZ "MAX mini" | Trixell pixium 2430EZ "MAX mini" | Same |
| N/A | Trixell pixium 2430EZ3 "X.wi-D 24" | New for LUMINOS Q.namix T | |
| Digital imaging system | Fluorospot Compact | Fluorospot Compact Plus | Changed |
| Operating system Windows 10 | Operating system Windows 10 | Same | |
| Operated via mouse and keyboard | Operated via touch screen | Changed | |
| Image processing with Diamond View Plus | Image processing with myExam IQ | Slightly different, based on same processing software. Same as for reference device YSIO X.pree. | |
| N/A | AI-based Auto Cropping | New, Same as for reference device YSIO X.pree. | |
| Acquisition and Image processing parameters selected via Organ Programs | Acquisition and Image processing parameters selected via clinical protocols | Changed, same as for reference device YSIO X.pree. | |
| Display | 19" Monitor | 24" and 32" Touch Monitors | Changed, new touch Monitors available |
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Other Features and Components
| Feature | Predicate device Luminos Agile Max | Subject device LUMINOS Q.namix T | Comment |
|---|---|---|---|
| Ceiling Stand (Second Plane) | Ysio Max Ceiling Stand | YSIO X.pree Ceiling Stand | Changed, updated Ceiling Stand |
| Patient Table | Table with optional bucky tray | Table with optional bucky tray | Same |
| Standard tabletop | Standard tabletop and flat tabletop | Changed, optional flat tabletop is now available | |
| Wall stand | Wall stand with fixed detector and wall stand with bucky tray | Wall stand with fixed detector and wall stand with bucky tray | Same |
| Camera | N/A | Live camera for patient positioning and collimation | New, Same as for reference device YSIO X.pree. |
| AI based Automatic collimation | N/A | Auto Thorax, Auto Long-Leg/Full-Spine collimation | New, Same as for reference device YSIO X.pree. |
| Cropping | Auto Cropping | AI-based Auto Cropping | Changed, same AI-based cropping used as for reference device YSIO X.pree. |
| Indicator Lights | N/A | Indicator Light at tube stand (YSIO X.pree option) | New |
| Light below Digital Imaging Tower (DIT) | N/A | available | New |
| Foot Switch | Wired Footswitch | Wired and wireless Footswitch | New wireless foot switch |
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Table 7-2. Comparison of the Subject Device (LUMINOS Q.namix R) to the Predicate Device (Luminos dRF Max K173639)
| Feature | Predicate device Luminos dRF Max | Subject device LUMINOS Q.namix R | Comment |
|---|---|---|---|
| Regulation Description | System, x-ray, fluoroscopic, image-intensified, Solid State X-ray imager | System, x-ray, fluoroscopic, image-intensified, Solid State X-ray imager | Same |
| Regulation Number | 892.1650 | 892.1650 | Same |
| Classification Product Code | JAA, OWB | JAA, OWB | Same |
| Indications for use | Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA). The system may be used on pediatric, adult and bariatric patients. Luminos dRF Max is not for mammography examinations. | LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations. | Similar |
| X-Ray Generator | Polydoros F80 65/80 kW | Polydoros RFX 65/80 kW | Changed, new State of the Art Generator |
| X-Ray tube | OPTITOP 150/40/80/HC-100 | OPTITOP 150/40/80/HC-100 | Same |
| X-ray techniques | Radiography, Pulsed fluoroscopy, DSA and series exposure | Radiography, Pulsed fluoroscopy and series exposure | Changed, DSA function is not available at LUMINOS |
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| Feature | Predicate device Luminos dRF Max | Subject device LUMINOS Q.namix R | Comment |
|---|---|---|---|
| Q.namix R | |||
| Collimator | Digital Multileaf Collimator N | Digital Multileaf Collimator RFU | Changed, new collimator |
| Air kerma | Kerma X | Kerma X | Same |
| CARE | Combined Applications to Reduce Exposure | Combined Applications to Reduce Exposure | Same |
| Touch user interface on tube suspension | touchscreen in portrait format | touchscreen in landscape format | Changed, same touch user interface as for reference device YSIO X.pree is used |
| Digital Imaging | |||
| Fluoro Detector in table | Trixel pixium 4343F-4 "Max Dynamic" | Trixel pixium 4343F-5 "X.fluoro" | Changed, new version of the Fluoro detector |
| Fixed detector for wall stand | Trixell pixium 4343RCE "Max Static" | Trixell pixium 4343RCE "Max Static" | Same |
| Large mobile detectors | Trixell pixium 3543EZh „MAX wi-D" | Trixell pixium 3543EZh „MAX wi-D" | Same |
| N/A | Trixell pixium 3543EZ3 "X.wi-D 35" | New, Same as for reference device YSIO X.pree. | |
| N/A | Trixell pixium 4343EZ3 "X.wi-D 43" | New, Same as for reference device YSIO X.pree. | |
| Small mobile detector | Trixell pixium 2430EZ "MAX mini" | Trixell pixium 2430EZ "MAX mini" | Same |
| N/A | Trixell pixium 2430EZ3 "X.wi-D 24" | New for LUMINOS Q.namix R | |
| Digital imaging system | Fluorospot Compact | Fluorospot Compact Plus | Changed |
| Operating system Windows 10 | Operating system Windows 10 | Same | |
| Operated via mouse and keyboard | Operated via touch screen | Changed | |
| Image processing with Diamond View Plus | Image processing with myExam IQ | Slightly different, based on same processing software. Same as for reference device YSIO X.pree. | |
| N/A | AI-based Auto Cropping | New, Same as for reference device YSIO X.pree. | |
| Acquisition and Image processing parameters selected via Organ Programs | Acquisition and Image processing parameters selected via clinical protocols | Changed, same as for reference device YSIO X.pree. | |
| Display | 19" Monitor | 24" and 32" Touch Monitors | Changed, new touch Monitors available |
Other Features and Components
| Feature | Predicate device Luminos dRF Max | Subject device LUMINOS Q.namix R | Comment |
|---|---|---|---|
| Ceiling Stand (Second Plane) | Ysio Max Ceiling Stand | YSIO X.pree Ceiling Stand | Changed, updated Ceiling Stand |
| Patient Table | Table with optional bucky tray | Table with optional bucky tray | Same |
| Standard tabletop | Standard tabletop and flat | Changed, optional flat |
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| Feature | Predicate device Luminos dRF Max | Subject device LUMINOS Q.namix R | Comment |
|---|---|---|---|
| tabletop | tabletop is now available | ||
| Wall stand | Wall stand with fixed detector and wall stand with bucky tray | Wall stand with fixed detector and wall stand with bucky tray | Same |
| Camera | N/A | Live camera for patient positioning and collimation | New, Same as for reference device YSIO X.pree. |
| AI based Automatic collimation | N/A | Auto Thorax, Auto Long-Leg/Full-Spine collimation | New, Same as for reference device YSIO X.pree. |
| Cropping | Auto Cropping | AI-based Auto Cropping | Changed, Same AI-based cropping used as for reference device YSIO X.pree. |
| Indicator Lights | N/A | Indicator Light at tube stand (YSIO X.pree option) | New for LUMINOS Q.namix R |
| Mood Light | N/A | Available | New for LUMINOS Q.namix R |
| Foot Switch | Wired Footswitch | Wired and wireless Footswitch | New wireless foot switch |
Table 7-3. Comparison of the Subject Devices (LUMINOS Q.namix T) to the Reference Device (YSIO X.pree, K 233543)
| Feature | Reference device YSIO X.pree | Subject device LUMINOS Q.namix T | Comment |
|---|---|---|---|
| Camera | Live camera for patient positioning and collimation | Live camera for patient positioning and collimation | Same |
| AI based Automatic collimation | Auto Thorax, Auto Long-Leg/Full-Spine collimation | Auto Thorax, Auto Long-Leg/Full-Spine collimation | Same |
| Cropping | AI-based Auto Cropping | AI-based Auto Cropping | Same |
| Digital imaging system | Image processing with myExam IQ | Image processing with myExam IQ | Same |
| Acquisition and Image processing parameters selected via clinical protocols | Acquisition and Image processing parameters selected via clinical protocols | Same | |
| Large mobile detectors | Trixell pixium 3543EZ3 "X.wi-D 35" | Trixell pixium 3543EZ3 "X.wi-D 35" | Same |
| Trixell pixium 4343EZ3 "X.wi-D 43" | Trixell pixium 4343EZ3 "X.wi-D 43" | Same |
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Table 7-4. Comparison of the Subject Devices (LUMINOS Q.namix R) to the Reference Device (YSIO X.pree, K 233543)
| Feature | Reference device YSIO X.pree | Subject device LUMINOS Q.namix R | Comment |
|---|---|---|---|
| Camera | Live camera for patient positioning and collimation | Live camera for patient positioning and collimation | Same |
| AI based Automatic collimation | Auto Thorax, Auto Long-Leg/Full-Spine collimation | Auto Thorax, Auto Long-Leg/Full-Spine collimation | Same |
| Cropping | AI-based Auto Cropping | AI-based Auto Cropping | Same |
| Digital imaging system | Image processing with myExam IQ | Image processing with myExam IQ | Same |
| Acquisition and Image processing parameters selected via clinical protocols | Acquisition and Image processing parameters selected via clinical protocols | Same | |
| Large mobile detectors | Trixell pixium 3543EZ3 "X.wi-D 35" | Trixell pixium 3543EZ3 "X.wi-D 35" | Same |
| Trixell pixium 4343EZ3 "X.wi-D 43" | Trixell pixium 4343EZ3 "X.wi-D 43" | Same |
Table 7.5. Additional Comparison of Subject Devices (LUMINOS Q.namix T and LUMINOS Q.namix R) to Predicate Devices (Luminos dRF Max and Luminos Agile Max)
| System Function | Luminos Agile Max (Predicate) | Luminos dRF Max (Predicate) | LUMINOS Q.namix T | LUMINOS Q.namix R |
|---|---|---|---|---|
| Fluoroscopy outside of the Examination Room | X | X | ||
| Fluoroscopy at the table next to the patient | X | X | ||
| Tube over the table | X | X | ||
| Tube under the table | X | X | ||
| Second Plane YSIO X.pree (option) | X | X | ||
| Second Plane Ysio Max (option) | X | X |
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8. Summary of Non-Clinical Tests:
The LUMINOS Q.namix T/LUMINOS Q.namix R systems were tested and comply with the voluntary standards listed in the table below:
Table 8. Non-clinical performance testing
| Standards Development Organization and Reference Number | Title of Standard |
|---|---|
| ANSI AAMI 60601-1, 2020 Ed. 3.2 | Medical Electrical Equipment - Part 1: General Requirements for Safety |
| 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 |
| IEC 60601-1-3: Edition 2.2, 2021 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60601-2-28, 2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-54 2018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| IEC 60601-1-6 2020 Ed 3.2 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
| IEC 62366-1 2020 Ed 1.1 | Medical devices – Application of usability engineering to medical devices |
| ISO 14971: 2019 | Medical devices – application of risk management to medical devices |
| IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle processes |
| IEC 61910-1: 2014, Ed 1.0 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy |
| NEMA PS 3.1 - 3.20 2023e | Digital Imaging and Communications in Medicine (DICOM) Set |
| ISO EN ISO 10993-1 Fifth edition 2018 | Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process |
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The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirement Specification Reviews
- Design Reviews
- Integration testing (System verification and validation)
9. Summary of Clinical Tests:
For the new detectors, X.fluoro and X.wi-D24, expert evaluations according to "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" have been conducted at the University Hospital Augsburg in Germany, Klinikum rechts der Isar Munich in Germany, Herz-Jesu-Krankenhaus Münster/Hiltrup in Germany and ZAS Jan Palfijn Hospital of Merksem in Belgium. The evaluation shows that the images are acceptable for diagnostic in radiography & fluoroscopy.
A US board-certified radiologist evaluated the detector X.fluoro (Pixium 4343F-5) in a clinical image quality evaluation. He evaluated multiple images and fluorography studies from different body regions. He determined that the images and fluorography studies with this detector were qualified for proper diagnosis.
10. General Safety and Effectiveness Concerns:
The Instructions for Use (IFU) are included within the device labeling, and the information provided enables the user to operate the device safely and effectively. Several safety features, including visual and audible warnings, are incorporated into the system design. In addition, the device is continually monitored, and if an error occurs, the system functions will be blocked, and an error message will be displayed.
Furthermore, the operators are healthcare professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
11. Conclusion as to Substantial Equivalence:
The LUMINOS Q.namix T and LUMINOS Q.namix R are substantially equivalent to the predicate devices, Luminos Agile Max and Luminos dRF Max. The LUMINOS Q.namix T/LUMINOS Q.namix R systems have similar indications for use that do not impact the overall intended use, the same fundamental scientific technology, and the same performance characteristics as the predicate devices. According to this submission material and the documentation provided, Siemens concludes that the LUMINOS Q.namix T and LUMINOS Q.namix R are substantially equivalent to the predicate devices.
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12. Guidance documents:
The following FDA guidance documents were utilized in this Premarket Notification:
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
Document issued on October 20, 2006
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission - Guidance for Industry and Food and Drug Administration Staff
Document Issued on September 27, 2023
Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Document issued on July 11, 2016
Content of Premarket Submissions for Device Software Functions - Guidance for Industry and FDA Staff
Document issued on June 14, 2023
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Document issued on September 14, 2018.
The 510(k) Program: Evaluation Substantial Equivalent in Premarket Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff
Document issued on July 28, 2014.
Pediatric Information for X-ray Imaging Device Premarket Notifications- Guidance for Industry and Food and Drug Administration Staff
Document issued on November 28, 2017
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff
Document issued on September 1, 2016
Radio Frequency Wireless Technology in Medical Devices- Guidance for Industry and Food and Drug Administration Staff
Document issue on August 13, 2013
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.