TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

K242015 · DRGEM Corporation · IZL · Dec 16, 2024 · Radiology

Device Facts

Record IDK242015
Device NameTOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
ApplicantDRGEM Corporation
Product CodeIZL · Radiology
Decision DateDec 16, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1720
Device ClassClass 2

Intended Use

The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis.

Device Story

Mobile X-ray system for bedside imaging of immobile patients. System comprises high-voltage X-ray generator, tube assembly, motorized collimator, and digital flat panel detector (FPD). Operator selects anatomical study on touch-screen console; software automatically sets exposure technique. X-rays pass through patient to FPD, generating digital radiographic image. Used in clinical facilities by trained medical professionals. RADMAX software processes images for display, annotation, and measurement. System features motorized drive for mobility and optional collapsible column. Output aids clinical diagnosis by providing anatomical images. Benefits include diagnostic capability for patients unable to travel to radiology department.

Clinical Evidence

Bench testing only. Validation testing evaluated input/output functions and system performance against predetermined criteria. Compliance with IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54, and other relevant standards confirmed safety and effectiveness.

Technological Characteristics

Mobile X-ray system; 32kW/40kW output; 40-150kV range. Includes high-frequency generator, motorized collimator, and wireless FPDs. 21.5" capacitive touch monitor. Connectivity via DICOM. Software (RADMAX) performs image processing. Complies with IEC 60601 series, ISO 14971, and NEMA PS 3.1-3.20.

Indications for Use

Indicated for obtaining human anatomical images of patients unable to be moved to a radiology department for medical diagnosis. Not intended for mammography, bone density, fluoroscopy, or angiography.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ December 16, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. DRGEM Corporation % Arim Kim Regulatory Affairs | Engineer 7F, E-B/D Gwangmyeong Techno-Park 60, Haan-ro GwangMyeong-si, Gyeonggi 14322 SOUTH KOREA Re: K242015 Trade/Device Name: TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 10, 2024 Received: December 3, 2024 Dear Arim Kim: 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. {1}------------------------------------------------ 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 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-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 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-device-advicecomprehensive-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-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-regulatory {2}------------------------------------------------ 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 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242015 Device Name TOPAZ Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D) #### Indications for Use (Describe) The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis. | 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;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the logo is the text "Your Best Healthcare" in a smaller, lighter font. # 510(k) Summary # K242015 This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ## I. SUBMITTER [21 CFR 807.92(a) (1)] DRGEM Corporation 7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-Ro Gwangmyeong-Si Gyeonggi, KR 14322 Email: arkim@drgem.co.kr TEL: +82-70-4901-2743, FAX: +82-2-869-8567 Contact Person: Ms. Arim KIM, Engineer | Regulatory Affairs Date Prepared: June 15, 2024 #### II. PROPOSED DEVICE INFORMATION [21 CFR 807.92(a) (2)] | Product Name: | TOPAZ Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D) | |--------------------------|----------------------------------------------------------| | Common Name: | Mobile x-ray system | | Classification Name: | Mobile x-ray system | | Product Code: | IZL | | Regulation Number: | 892.1720 | | Associated Product Code: | MQB | | Regulatory Class: | II | #### III. PREDICATE DEVICES INFORMATION [21 CFR 807.92(a) (3)] Product Name: TOPAZ Mobile DR System (Models: TOPAZ-32D, TOPAZ-40D) Common Name: Mobile x-ray system Classification Name: Mobile x-ray system 510(k) Number: K201124 Product Code: IZL Requlation Number: 892.1720 Regulatory Class: ============================================================================================================================================================================== #### IV. DEVICE DESCRIPTION [21 CFR 807.92(a) (4)] #### ● Device Features: #### · TOPAZ Mobile X-ray System "TOPAZ" system is a system providing state-of-the-art image quality, user interface. "TOPAZ" system may be moved quietly and smoothly with motor drive mechanism "TOPAZ" system has a basic type column, and a collapsible type column option with a trendy design that allows driving without disturbing the front view. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for DRGEM. The logo has the text "DRGEM" in bold, with "DR" in black and "GEM" in teal. Below the logo is the text "Your Best Healthcare" in a smaller, lighter font. The core part of x-ray source adopts high quality tube assembly, motorized x-ray collimator. HV cable assembly and High Voltage X-Ray Generator. Touch screen LCD based x-ray control console provides user-friendly interface and easy technique selection. Collimator supports high accuracy for selected x-ray field size over any SID. Direct radiography via flat panel detector improves-exam speed and comfort with efficiency. Digital flat panel detector with Csl screen provides spatial resolution, MTF, DQE and stability based on fine pixel pitch. Selection of an anatomical study on the Digital Imaging Software automatically sets up the x-ray generator's preprogrammed exposure technique. The types of "TOPAZ" system are divided into TOPAZ-32D, and TOPAZ-40D according to maximum power and mA. The higher the maximum output, the wider the mA range to choose from, giving the user more technical options to choose from. #### ● Device Identification: The "TOPAZ Mobile X-ray System" consists of a tube assembly. x-ray collimator. High Voltage X-Rav Generator, detector and mechanical parts for mobility. #### ● Device Characteristics: #### ·Software The subject device 'TOPAZ Mobile X-ray System' use software (including firmware). Its S/W (RADMAX) can perform processing the radiological image acquired from Solid State X-ray Imaging Device. Software being used is identical to the predicate device 'TOPAZ Mobile X-ray System', and its LOC (Level of Concern) is ' Basic Documentation Level'. Accordingly, this software (RADMAX) is based on predicate device 'TOPAZ Mobile X-ray System'. #### ·Software Level Determination #### Basic Documentation Level The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets all images and information being displayed and printed. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for DRGEM, a healthcare company. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the company name is the tagline "Your Best Healthcare" in a smaller, lighter font. #### ·Cybersecurity This device complies with cybersecurity requirements by ensuring the confidentiality, integrity, and availability of data and systems. Potential vulnerabilities were identified through cybersecurity risk analysis, which included threat modeling, risk assessment, and the development of a software bill of materials. The design integrates security controls, such as authentication, encryption, integrity verification, event detection and logging, retention, recovery and secure software updates. Verification and tests were conducted to ensure the effectiveness of the implemented cybersecurity controls. The product labeling includes cybersecurity-related information, and users are provided with quidance and training on instruction for use. #### ● Environment of Use: This 'TOPAZ Mobile X-ray System' is for use by medical professional Facility. To prevent excess radiation exposure to patient and operator from either primary or secondary radiation, this 'TOPAZ Mobile X-ray System' must be operated and serviced by trained personnel who are familiar with the safety precautions required. #### ● Brief Written Description of the Device: The operating principles are as follows. The irradiation conditions are 40 to 125 (150) kVp at the photographing site, and the tube current is 10 to 400 (500) mA. When X-rays generated under X-ray irradiation conditions enter the X-ray Film or Flat Panel detector, the film or flat panel detects X-rays incident through the incident surface during X-ray irradiation, and finally generates a radiographic image when X-ray irradiation is completed. #### V. INDICATION FOR USE [21 CFR 807.92(a) (5)] The 'TOPAZ Mobile X-ray System' is intended for use in obtaining human anatomical images of patients who cannot be moved to the radiology department for medical diagnosis. #### VI. TECHNOLOGICAL CHARACTERISTICS [21 CFR 807.92(a) (6)] The Subject device 'TOPAZ Mobile X-ray System' (Model: TOPAZ-32D, TOPAZ-40D) is based on the Predicate Device (TOPAZ Mobile DR System, K201124) including the system control, Indication for use and mechanical design. The differences between the subject device and the predicate device have been thoroughly tested and verified for safety and effectiveness by an accredited Safety and EMC testing laboratory. This 510(k) submission describes some modifications to the previously cleared predicate devices the 'TOPAZ Mobile DR System' (K201124). The changes to the predicate 'TOPAZ Mobile DR System' (K201124) include: {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for DRGEM. The letters "DRG" are in black, and the letters "EM" are in teal. Below the logo is the text "Your Best Healthcare" in a smaller font. # Software update from TPZ IWS 1.00.01 to RADMAX 1.02.09 - 1) Imaging Software Model Name Change: We have changed the model name of our imaging software from 'TPZ IWS (XGRADMAX)' to 'RADMAX'. - Graphical user interface (GUI): GUI of system software updated in order to improve 2) the look and feel of user interface for better visibility & faster workflow. - Image Processing Module added (Module 3, 4): We conducted performance 3) verification of Flat Panel detectors compared to existing image processing modules. Verification and Validation testing concluded no impact on safety and effectiveness. ## Component Change - 1) 21.5" capacitive touch monitor is applied : 21.5" monitor is applied for improved viewing angle and wide screen. - 2) New Collapsible Column Stand Option have been Added (Basic type, Collapsible type - Optional) : We have added a new Collapsible column type stand option to our product. This collapsible type column stand features a trendy design that allows driving without disturbing the front view. - 3) Addition of detector : 4343W, Mars1417X, Mars1717X, Luna1012X, A1417MCW, A1717MCW, F1417MCW ## ·10x12 inch Wireless Flat Panel detectors have been added ·Luna1012X manufactured by IRAY Technology, FDA Cleared K221345 # ·14x17 inch Wireless Flat Panel detectors have been added ·Mars1417X manufactured by IRAY Technology, FDA Cleared K210316 ·A1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930 ·F1417MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930 # ·17x17 inch Wireless Flat Panel detectors have been added ·4343W manufactured by Varex Imaging Corp, FDA Cleared K202572 ·Mars1717X manufactured by IRAY Technology, FDA Cleared K210314 ·A1717MCW manufactured by H&abyz Co., Ltd., FDA Cleared K223930 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for DRGEM. The letters "DR" are in bold black font, while "GEM" is in a teal color. Below the company name is the text "Your Best Healthcare" in a smaller font size. # VII.SUBSTANTIAL EQUIVALENCE [21 CFR 807.92(b)] # Substantial Equivalence Comparison Table | Item | Subject Device | Predicate Device | Impact of Differences | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | TOPAZ Mobile X-ray System | TOPAZ Mobile DR System | The TOPAZ Mobile DR System<br>has been renamed to the<br>TOPAZ Mobile X-ray System.<br>This is a simple model name<br>change, and the differences<br>between the subject device and<br>the predicate device do not<br>affect the safety or efficacy of<br>the modified device. | | 510(k) number | K242015 | K202572 | - | | Manufacturer | DRGEM Corporation | DRGEM Corporation | - | | Model Name | TOPAZ-32D<br>TOPAZ-40D | TOPAZ-32D<br>TOPAZ-40D | Same as predicate | | Appearance | Image: Basic type | Image | Yes, there is a difference<br>Collapsible type Column Stand<br>Option have been Added<br>Models have been tested<br>against International Safety and<br>EMC Standards. Any differences<br>between the subject device and<br>predicate device do not change<br>or add new potential safety risks<br>It is our determination that there<br>is "No negative impact on safety<br>or effectiveness" and there are<br>no new potential<br>or increased safety risks<br>concerning this difference<br>Same as predicate | | | Image: Collapsible type | | | | Indications<br>for Use | The 'TOPAZ Mobile X-ray System' is<br>intended for use in obtaining human<br>anatomical images of patients who<br>cannot be moved to the radiology<br>department for medical diagnosis. | The TOPAZ Mobile DR System, is a<br>mobile X-ray imaging system, for the<br>purpose of acquiring X-ray images of the<br>desired parts of a patient's anatomy.<br>This device is not intended for<br>mammography, bone density,<br>fluoroscopy and angiography<br>applications. | Same as predicate<br>The indications for use of the<br>previous TOPAZ Mobile DR<br>System and the current TOPAZ<br>Mobile X-ray System is<br>essentially the same.<br>The previous device described<br>the general intended use of<br>acquiring X-ray images of the<br>desired body part of the patient.<br>The current device emphasizes<br>the more specific situation of<br>acquiring images of immobile<br>patients.<br>Therefore, the intended use of<br>the two devices is essentially the<br>same, with only differences in<br>wording.<br>This device is not intended for<br>mammography, bone density,<br>fluoroscopy and angiography<br>applications.<br>These contraindications apply to<br>both the previous TOPAZ Mobile | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains a logo for "DRGEM Your Best Healthcare". The word "DR" is in black, and the word "GEM" is in teal. The words "Your Best Healthcare" are in a smaller font and are in black. | | | | | | DR System and the current<br>TOPAZ Mobile X-ray System.<br>This matters are specified in the<br>warning and contraindication<br>sections on pages 13 and 18 of<br>the Operation Manual<br>(RMD1311-009) | |--------------------------------|--------------------------------------|-------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 1. High Frequency X- ray Generator | | | | | | Output Power<br>Rating (kW) | 32kW | 40kW | 32kW | 40kW | | | mA Range | Max. 400mA | Max. 500mA | Max. 400mA | Max. 500mA | Same as predicate | | KV Range | 40 ~125 kV<br>(option: 150kV) | 40 ~ 125 kV<br>(option: 150kV) | 40 ~125 kV<br>(option: 150kV) | 40 ~ 125 kV<br>(option: 150kV) | | | mAs Range | 0.1 ~500mAs | 0.1 ~500mAs | 0.1 ~500mAs | 0.1 ~500mAs | | | | 2. X-ray tube housing Assembly | | | | | | Configuration<br>model | E7239X / CANON | | E7239X / CANON | | | | | E7242X / CANON | | E7242X / CANON | | | | | E7299X / CANON | | E7299X / CANON | | | | | E7876X / CANON | | E7876X / CANON | | | | | E7884X / CANON | | E7884X / CANON | | | | | DXT-8M / DRGEM | | DXT-8M / DRGEM | | | | | DXT-11M / DRGEM | | DXT-11M / DRGEM | | | | | DXT-10M / DRGEM | | DXT-10M / DRGEM | Same as predicate | | | | DXT-12M / DRGEM | | DXT-12M / DRGEM | | | | Focal spot | 1.0/2.0mm, | | 1.0/2.0mm, | | | | | 0.3/1.0mm, | | 0.3/1.0mm, | | | | | 0.6/1.2mm, | | 0.6/1.2mm, | | | | | 0.6/1.5mm | | 0.6/1.5mm | | | | Target angle | 12° to 16 | | 12° to 16 | | Yes, there is a difference.<br>The addition of the Collapsible<br>type Column Stand Option<br>adds a 330 degree column<br>rotation range. Models have<br>been tested against<br>International Safety and EMC<br>Standards. Any differences<br>between the subject device<br>and predicate device do not<br>change or add new potential<br>safety risks. It is our<br>determination that there is "No<br>negative impact on safety or<br>effectiveness" and there are<br>no new potential or increased<br>safety risks concerning this<br>difference | | | depending upon the Tube | | depending upon the Tube | | | | Colum<br>rotation<br>range | ± 325 degrees | | ± 325 degrees, | | | | | ± 330 degrees | | | | | | Tube<br>(Arm axis) | ± 180 degrees | | ± 180 degrees | | | | Tube axis<br>rotation<br>range | -30~+90 degrees | | -30~+90 degrees | Same as predicate | | | Max Tube<br>Voltage | 125kV, 150kV | | 125kV, 150kV | | | | | 3. Collimator (Beam Limiting Device) | | | | | | | Configuration<br>model | R108/R108F | R108/R108F | Yes, there is a difference.<br>Collimator Configuration<br>Models have been partially<br>deleted based on predicate<br>device. | | | | | DXC-RML | DXC-RML/DXC-RMH | It is our determination that<br>there is "No negative impact on<br>safety or effectiveness" and<br>there are no new potential<br>or increased safety risks<br>concerning this difference | | | | Lamp Type | LED lamp | LED and Halogen lamp | | | | | 4. Solid State X-ray Imaging Device | | | | | | | | - | PaxScan4336W / VAREX | There are differences between<br>the added detectors and the<br>original detector used in the<br>predicate device. All detectors<br>have been tested for<br>compatibility with TOPAZ via<br>internal testing and the added<br>detectors have been cleared by<br>FDA 510(k)s. It is our<br>determination that the added<br>detectors do not have a<br>negative impact on safety or<br>efficacy and there are no new<br>potential or increased safety<br>risks concerning these<br>differences. | | | | Flat panel<br>Detector | PaxScan4336W v4/ VAREX | PaxScan4336W v4/ VAREX | | | | | | XRpad2 3025 HWC-M / VAREX | XRpad2 3025 HWC-M / VAREX | | | | | | XRpad2 4336 HWC-M / VAREX | XRpad2 4336 HWC-M / VAREX | | | | | | XRpad2 4343 HWC-M / VAREX | XRpad2 4343 HWC-M / VAREX | | | | | | Mano4336W / IRAY | Mano4336W / IRAY | | | | | | Mano4343W / IRAY | Mano4343W / IRAY | | | | | | 4343W / VAREX | - | | | | | | Mars1417X / IRAY | - | | | | | | Mars1717X / IRAY | - | |…
Innolitics
510(k) Summary
Decision Summary
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