(85 days)
This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
These are modified versions of the predicate mobile digital diagnostic x-ray systems. They feature motorized movement and full battery operation. Various Canon digital X-ray panels are supplied with the system. The Mobile X-Ray Unit MOVIX DReamy has a Basic configuration or Advanced configuration. The Mobile X-Ray unit MOVIX DReamy is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on MOVIX DReamy and it is displayed on touch screen. The MOVIX DReamy Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit MOVIX DReamy. This X-Ray generator for MOVIX DReamy Mobile X-Ray Unit has a radiogenic unit mounted on head-assembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit MOVIX DReamy is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES: XRR-3331 insert and E7886 insert. The Manual Beam Limiting Device is from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.
Based on the provided text, the MOVIX DReamy device is a mobile X-ray system. The document does not describe acceptance criteria for an AI/ML device or a study proving that the device meets such criteria. Instead, it is a 510(k) premarket notification for a mobile X-ray system, establishing substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them based on the given document. The document describes the device, its intended use, comparison to a predicate device, and compliance with various international standards, but it explicitly states that no clinical testing was required to establish substantial equivalence.
The relevant sections for this request (AI/ML acceptance criteria and performance study) are not present in this document because it pertains to a different type of medical device clearance.
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November 3, 2021
Stephanix % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
Re: K212515
Trade/Device Name: MOVIX DReamy Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MQB Dated: August 5, 2021 Received: August 10, 2021
Dear Mr. Kamm:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212515
Device Name MOVIX DReamy
Indications for Use (Describe)
This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
| 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) |
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510(k) Summary: 510(k) Number K212515
Image /page/3/Picture/1 description: The image shows the logo for Stephanix Medical Imaging Solutions. The logo features a blue square with a stylized "X" inside, followed by the word "STEPHANIX" in large, bold, blue letters. Below the company name, the words "MEDICAL IMAGING SOLUTIONS" are written in smaller, lighter blue letters.
Stephanix 10 Rue Jean Moulin La Ricamarie Auvergne-Rhone-Alpes, FR 42150 (Tel): +33 4 77 47 81 60 Registration Number: 3006972752 Date Prepared: October 22, 2021 Contact: Sandie Perret Quality Manager
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- Identification of the Device: Trade/Device Name: MOVIX DReamy Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
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- Equivalent legally marketed device: K192011 Trade/Device Name: PhoeniX Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL, MQB. Common/Usual Name: Digital Mobile Diagnostic X-Ray System
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- Reference devices: We employ these cleared devices (K131106, K133693, K170332 and K171270 with software update cleared in K190368) without modification: Trade/Device Name: Canon Digital X-ray Panels CANON CXDI-401C Wireless CANON CXDI-701C Wireless CANON CXDI-801C Wireless CANON CXDI-710C Wireless CANON CXDI-810C Wireless CANON CXDI-410C Wireless Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB
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- Indications for Use: This Digital Mobile Diagnostic X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
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Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
-
- Description of the Device: These are modified versions of the predicate mobile digital diagnostic x-ray systems. They feature motorized movement and full battery operation. Various Canon digital X-ray panels are supplied with the system. (See list above.) The Mobile X-Ray Unit MOVIX DReamy has a Basic configuration or Advanced configuration. Advanced configurations include:
- Second screen on head assembly.
- Smooth movements of head assembly.
- Telescopic arm in four steps instead three steps for basic configuration.
The Mobile X-Ray unit MOVIX DReamy is provided with touch screen to operate as a control console. The Digital Imaging System is composed by image receptors and application for image acquisition (control console & image processing controller). The Image acquisition software "CANON CXDI Control Software NE" runs on MOVIX DReamy and it is displayed on touch screen. It is the user interface and compatible digital detectors are listed above. All have FDA Clearance. The Advanced configuration has a second Touch Screen Monitor located on head-assembly.
The MOVIX DReamy Mobile X-Ray Unit is provided with separate battery packs for X-Ray generation and motorized movements of the unit can operate connected to mains or in stand-alone mode, that is, operating without mains being present or unplugged from mains. The unit is connected to mains to charge the batteries; Rating: the input voltage range goes from 100 V~ to 240 V~, 1 phase, 1.1 kVA. New X-ray generator (model SHFM) is mounted on Battery Mobile X-Ray unit MOVIX DReamy This X-Ray generator for MOVIX DReamy Mobile X-Ray Unit has a radiogenic unit mounted on headassembly and comprising an X-ray tube with rotating anode and its circuit for high voltage. The electronic and associated software to control the X-ray generation are placed on mobile cart. The Battery Mobile X-Ray Unit MOVIX DReamy is provided with different output powers: 20 kW, 32 kW, 40 kW and 50 kW. There are available two X-ray tube inserts with rotating anode manufactured by CANON ELECTRON TUBES & DEVICES:
- XRR-3331 insert.
- E7886 insert.
The Manual Beam Limiting Device is from Ralco, model: R108 F. External interface (controls) and covers are provided by Sedecal. There are two versions of collimator assembly, Basic and Advanced.
Image /page/4/Picture/10 description: The image is a comparison of two medical devices, labeled "Basic" and "Advanced". The "Basic" device has a white and gray body with a black control panel that has two knobs and a port. The "Advanced" device has a similar white and gray body, but it also has a display screen and additional components.
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| Basic | Advanced |
|---|---|
| Knobs to adjust the collimator blades.Collimator light push button.Rail system to install external additionalfiltration.Measuring tape to measure the SID.Double laser (optional)Motorized filter (optional) | Knobs to adjust the collimator blades.Collimator light push button.Rail system to install external additional filtration.Measuring tape to measure the SID.Double laser (optional)Motorized filter (optional)Rear knobs to adjust the collimator blades (optional).Additional options selectable with TFT:Variable additional filtration.Collimator blades aperture. |
The Battery Mobile X-Ray Unit MOVIX DReamy is driven by holding the handlebar with the hands. It is provided to internal sensor (gauges) that control the direction and speed of each wheel depending the force applied by the operator.
The handlebar is capacitive handlebar and when operator put his handlebar the movements are enabled. The height of handlebar is adaptable to improve the user commodity.
Four buttons are provided on the hand grips placed on Head-Assembly. They control the motion of each driving wheel and allow fine positioning adjustment of the patient (movements with low speed because this control is not intended for long displacement).
The Battery Mobile X-Ray unit MOVIX DReamy supports:
- Ethernet communication (with hospital and backup cable for digital detectors) ●
- Wireless Wi-Fi communications (with digital detectors and remote hand switch). The wireless . communication is supported by Access Point and one single internal antenna.
Options:
Barcode scanner for register patient information. Dosimetry for Dose Area Product (DAP).
Tube Arm specifications:
-Counterbalanced tube arm.
- Tube arm reach 1220 mm horizontally for both configurations (Advanced option with 4 steps and Basic option with 3 steps).
-Column rotation: ± 317 °.
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Maximum SID to floor is 2020 mm for both configurations.
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Minimum SID to floor is 530 mm for both configurations.
Mobile Unit:
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Weight: the heaviest configuration 520 kg.
-Size (L x W x H): -
Mobile on parking position: 1220 x 540 x 1290 mm. o
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Mobile fully extended (Telescopic column & Telescopic arm): 2290 x 1790 x 2230 mm. O
-Frontal anti-collision system.
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Motorized unit up to 5,5 km/h.
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Motor drive with two independent drive motors, one for each wheel (forward and reverse).
-Touch screen console:
- o Main control console: 19 inch.
- Additionally, second touch screen of 8.4 inch for Advanced configuration O
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Substantial Equivalence Chart 6)
| Characteristic | Phoenix K192011 (Sedecal) | MOVIX DReamy |
|---|---|---|
| Indicationsfor Use: | Intended for use by a qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull, spinalcolumn, chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting,standing, or lying in the prone or supineposition. Not for mammography | This Digital Mobile Diagnostic X-Ray System isIntended for use by a qualified/trained doctoror technician on both adult and pediatricsubjects for taking diagnostic radiographicexposures of the skull, spinal column, chest,abdomen, extremities, and other body parts.Applications can be performed with the patientsitting, standing, or lying in the prone or supineposition. Not for mammography. (SAME,device description added) |
| Configuration | Mobile System with digital x-ray paneland image acquisition computer | SAME |
| X-rayGenerator(s) | kW rating: 20 kW, 32 kW, 40 kW and 50 kW.kV range: from 40 kV to 150 kV in 1 kV steps.mA range: from 10 mA to 630 mA / 640 mA /650 mA. | SAME |
| Collimator | Ralco R108F | SAME |
| Photos | Image: Phoenix K192011 | Image: MOVIX DReamy |
| Digital X-rayPanelSupplied | CANON CXDI-401C WirelessCANON CXDI-701C WirelessCANON CXDI-801C WirelessPlus:CANON CXDI-710C WirelessCANON CXDI-810C WirelessCANON CXDI-410C Wireless | SAME |
| Characteristic | PhoeniX K192011 (Sedecal) | MOVIX DReamy |
| Software | Canon control software CXDI-NE | SAME |
| PanelInterface | Ethernet or Wi-Fi wireless | SAME |
| Meets USPerformanceStandard | YES 21 CFR 1020.30 | SAME |
| PowerSource | Universal power supply, from 100 V~ to240 V~. 1 phase, 1.1 kVA | SAME |
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- The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new devices are as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination.
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- Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. The digital panel software employed was already reviewed by FDA in K190368. Because the units are indicated for the pediatric population (as well as the adult population) we reviewed and took into account the FDA guidance Pediatric Information for X-ray Imaging Device Premarket Notifications.
The MOVIX DReamy Units have been tested to be in compliance with the following International Standards:
- a) IEC 60601-1:2005+A1:2012 (Edition 3.1)
- b) IEC 60601-1-2:2014 (Edition 4.0)
- c) IEC 60601-1-3:2008+A1:2013 (Edition 2.1)
- d) IEC 60601-2-54:2009+A1:2015 (Edition 1.1)
- e) IEC 60601-2-28:2010 (Edition 2.0)
- f) IEC 60601-1-6:2010 + A1:2013 (Edition 3.1)
- g) IEC 62304:2006 + A1:2016 (Edition 1.1)
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- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance.
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- Conclusion: After analyzing bench and clinical tests, it is the conclusion of STEPHANIX that the new MOVIX DReamy Digital Diagnostic Mobile X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.