Mobile X-ray unit (!M1)

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION October 24, 2025 Solutions for tomorrow AB % Martin Yngvesson Project manager Saxagårdsvägen 1 Väckelsång SWEDEN 36251 Re: K251710 Trade/Device Name: Mobile X-ray unit (!M1) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: June 30, 2025 Received: September 23, 2025 Dear Martin Yngvesson: 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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K251710 - Martin Yngvesson Page 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- {2} K251710 - Martin Yngvesson Page 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, Digitally signed by Gabriela M. Rodal -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) K251710 | | | Device Name Mobile X-ray unit (!M1) | | | Indications for Use (Describe) The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas. Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' 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." | | {4} Solutions for tomorrow October 24, 2025 # 510 (k) Summary # !M1 Mobile X-ray Unit # K251710 ## 1. Submitter Information Name of manufacturer: Solutions for tomorrow AB Address: Saxagårdsvägen 1 36251 Väckelsång Sweden Phone: +46 10 456 4500 Official FDA contact: Martin Yngvesson martin@solutionsfortomorrow.se +46 10 456 4502 Correspondent contact: Nan Jin njin@dms-imaging.com +33 78 848 6797 ## 2. Device Information Device Trade Name: Mobile X-ray Unit (!M1) Device Common Name: System, X-ray, Mobile Classification Name: Mobile x-ray system Regulation Number: 21 CFR 892.1720 Product Code: IZL Device Class: Class II Classification Panel: Radiology Solutions for tomorrow AB Address: Saxagårdsvägen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se {5} Solutions for tomorrow October 24, 2025 ## 3. Legally Marketed Predicate Device The following is the identified predicate device: Manufacturer: Solutions for tomorrow AB 510(k) Number: K241980 Device Trade Name: Mobile X-ray Unit (!M1) Device Common Name: Mobile x-ray system Classification Name: Mobile x-ray system Regulation Number: 21 CFR 892.1720 Product Code: IZL Device Class: Class II Classification Panel: Radiology ## 4. Device Description Summary The !M1 mobile X-ray system is a diagnostic mobile X-ray system utilizing digital radiography (DR) technology. The device consists of a self-contained x-ray generator, image receptor(s), imaging display, and software for acquiring medical diagnostic images both inside and outside of a standard stationary x-ray room. The !M1 system incorporates a flat-panel detector(s) that can be used wirelessly for exams such as in-bed projections. The system can also be used to expose CR phosphor screens or film. ## 5. Intended Use/Indications for Use The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas. Treatment areas are defined as professional health care facility environments where operators with medical training are continually present during patients' examinations. ## 6. Substantial Equivalence Comparison and Discussion ### 6.1 Indications for Use Comparison The indications for use are the same as for the predicate device. Solutions for tomorrow AB Address: Saxagårdsvägen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se {6} # Solutions for tomorrow October 24, 2025 # 6.2 Technological Comparison The subject of this Traditional 510(k) application is to integrate a new imaging system (including imaging software and flat panel detectors) manufactured by JPI Healthcare and an additional display monitor option. The introduced changes enhance the user experience and answer customer needs in a better way. Table 1. !M1 mobile X-ray unit | Parameter | Predicate Device | Subject Device | Equivalence | | --- | --- | --- | --- | | 510(k) number | K241980 | K251710 | / | | Manufacturer | Solutions for tomorrow AB | Solutions for tomorrow AB | EQUIVALENT | | Device Name | !M1 | !M1 | EQUIVALENT | | Regulation Number | 21 CFR 892.1720 | 21 CFR 892.1720 | EQUIVALENT | | Common Name | Mobile X-ray system | Mobile X-ray system | EQUIVALENT | | Classification Name | System, X-ray, Mobile | System, X-ray, Mobile | EQUIVALENT | | Product Code | IZL | IZL | EQUIVALENT | | Device Class | Class II | Class II | EQUIVALENT | | Indications for use | The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.Treatment areas are defined as professional healthcare facility environments where operators with medical training are continually present during patients' examinations. | The device is designed to perform general radiography x-ray examinations on all pediatric and all adult patients, in all patient treatment areas.Treatment areas are defined as professional healthcare facility environments where operators with medical training are continually present during patients' examinations. | EQUIVALENT | | Collimator | Manual or Motorized, single layer | Manual or Motorized, single layer | EQUIVALENT | | Imaging system (including software and detector) Compatibility | Konica Minolta imaging systemOrCanon imaging systemOrVieworks imaging system | Konica Minolta imaging systemOrCanon imaging systemOrVieworks imaging systemOrJPI Healthcare imaging system | MODIFIED | Solutions for tomorrow AB Address: Saxagårdsvagen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se {7} i Solutions for tomorrow October 24, 2025 Table 2. Integrated and compatible imaging system | Parameter | Predicate Device | Subject Device | Equivalence | | --- | --- | --- | --- | | Konica Minolta Imaging system | | | NO CHANGE | | Device Name | SKR 3000 | SKR 3000 | EQUIVALENT | | Manufacturer | Konica Minolta | Konica Minolta | EQUIVALENT | | 510(k) | K223267 | K223267 | EQUIVALENT | | Canon Imaging system | | | NO CHANGE | | Device Name | Digital Radiography, Solid State X-ray Imager | Digital Radiography, Solid State X-ray Imager | EQUIVALENT | | Manufacturer | Canon Inc. | Canon Inc. | EQUIVALENT | | 510(k) | K230175 | K230175 | EQUIVALENT | | Viewworks Imaging system | | | NO CHANGE | | Device Name | VIVIX-S FW, VIVIX-S VW | VIVIX-S FW, VIVIX-S VW | EQUIVALENT | | Manufacturer | Viewworks Co., Ltd | Viewworks Co., Ltd | EQUIVALENT | | 510(k) | K221512, K200418 | K221512, K200418 | EQUIVALENT | | JPI Healthcare Imaging system | | | ADDITION | | Device name | | ExamVue Apex | MODIFIED | | 510(k) | | K244010 | MODIFIED | | Software Manufacturer | | JPI Healthcare Co, Ltd | MODIFIED | | Detector Manufacturer | | Thales | MODIFIED | | Indications for Use | | The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The ExamVue Apex flat panel x-ray detector system is not indicated for use in mammography. | MODIFIED | | Acquisition and Control Software | | ExamVue Duo (K213057) | MODIFIED | | Detector Models | | EVA 10W EVA 14W EVA 17W | MODIFIED | | Detector Type | | Amorphous Silicon | MODIFIED | | Scintillator | | Csl | MODIFIED | | Pixel Pitch | | 99 μm | MODIFIED | Solutions for tomorrow AB Address: Saxagårdsvagen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se {8} i Solutions for tomorrow October 24, 2025 Table 3. Display monitors | Parameter | Predicate Device | Subject Device | Equivalence | | --- | --- | --- | --- | | 510(k) number | K241980 | K251710 | / | | Type | 17": TFT - LCD LED backlight | 17": TFT - LCD LED backlight 18.5": TFT - LCD LED backlight | MODIFIED | | Active screen size | 17": 432.75mm diagonal | 17": 432,75mm diagonal 18.5": H408.96 * V230.04 mm | MODIFIED | | Pixel format | 17": H1280* V1024 | 17": H1280* V1024 18.5": H1920* V1080 | MODIFIED | | Color depth | 17": 16.7M colors | 17": 16.7M Colors 18.5": 16.7M Colors | MODIFIED | | White luminance (monitor only) | 17": 400 cd/m2 (Center 1 Point, Typ.) | 17": 400 cd/m2 (Center 1 Point, Typ.) 18.5": Typ. 350 cd/m2 | MODIFIED | | White luminance (with touch) | 17": 350 cd/m2 | 17": 350 cd/m2 18.5": 300 cd/m2 Min. | MODIFIED | | Viewing angle | 17": R/L 179° (type.), U/D 178° (type.) for CR<10 | 17": R/L 179° (type.), U/D 178° (type.) for CR<10 18.5": R/L 89°, U/D 89° | MODIFIED | Solutions for tomorrow AB Address: Saxagårdsvägen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se {9} Solutions for tomorrow October 24, 2025 | Contrast ratio | 17": 1000:1 | 17": 1000:1 18.5": 1000:1 | MODIFIED | | --- | --- | --- | --- | | Touch type | 17": Capacitive | 17": Capacitive 18.5": Capacitive | MODIFIED | ## 7. Non-clinical Tests Summary Integration testing comprising the !M1 system and ExamVue Apex imaging system demonstrates that the implementation was successfully performed. The new display monitor option has been thoroughly verified and meets all applicable standards. ## 7.1 Compliance with Standards !M1 mobile X-ray unit complies with the following standards: - IEC 62304 Edition 1.1 2015-05 CONSOLIDATED VERSION Medical devices software – Software life cycle processes - IEC 60601-2-54 Edition 2.0 2022-09 Medical Electrical Equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy - IEC 60601-2-28 Edition 3.0 2017-06 Medical electrical equipment – Part 2-28: Particular requirements for the safety and essential performance of X-ray tube assemblies for medical diagnosis - IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests - IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance - IEC 62366-1 Edition 1.0 2015-02 Medical devices – Part 1: Application of usability engineering to medical devices - ISO 15223-1 Fourth Edition 2021-07 Medical devices – Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - ISO 10993-1 Fifth Edition 2018-08 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process Solutions for tomorrow AB Address: Saxagårdsvagen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se {10} Solutions for tomorrow October 24, 2025 - ISO 14971 Third Edition 2019-12 Medical devices – Application of risk management to medical devices - ISO 13485 Third Edition 2016-03 Medical devices – Quality management systems – Requirements for regulatory purposes ## 7.2 Followed FDA Guidance - Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff - June 2023 - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff - June 2025 - Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff - November 2017 - Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff - October 2023 - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff - September 2023 - General Principles of Software Validation - Guidance for Industry and FDA Staff - January 2002 - Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff - August 2023 - Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff - February 2016 - Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff - June 2023 ## 8. Conclusion The !M1 mobile X-ray device with new imaging system and additional display monitor option has the same intended use, technology, materials, and uses most of the same components as the predicate device. The changes to the subject device have little to no impact on the safety or performance device, and no additional questions regarding safety or effectiveness have been raised. The fundamental scientific technology of the subject device included in this submission remains unchanged from the legally marketed predicated device (K241980). Therefore, the proposed device is substantially equivalent to the predicate device. Solutions for tomorrow AB Address: Saxagårdsvagen 1, S-362 51 Väckelsång, SWEDEN Phone: +46 10 456 45 00 Email: info@solutionsfortomorrow.se Web: http://www.solutionsfortomorrow.se