Who is the manufacturer of Definium Pace Select ET?

Ge Hualun Medical Systems Co. , Ltd. filed the 510(k) submission for Definium Pace Select ET (K242678).

What is the FDA product code for Definium Pace Select ET?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Definium Pace Select ET?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Definium Pace Select ET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Definium Pace Select ET

Q: What are the predicate devices for Definium Pace Select ET?

Definium Pace Select (K231892).

K242678 · Ge Hualun Medical Systems Co. , Ltd. · KPR · Oct 1, 2024 · Radiology

Device Facts

Record ID	K242678
Device Name	Definium Pace Select ET
Applicant	Ge Hualun Medical Systems Co. , Ltd.
Product Code	KPR · Radiology
Decision Date	Oct 1, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.

Device Story

Definium Pace Select ET is a stationary digital radiographic X-ray system; modular design includes 2-axis motorized tube stand, elevating table, motorized wall stand, high voltage generator, wireless detectors, and acquisition workstation. System captures X-ray signals; transforms inputs into digital diagnostic images for local review or DICOM network transmission. Operated by professionals in clinical settings. New features include motorized tube stand (vertical/angulation), auto-tracking for wall stand, auto-angulation, camera-assisted workflow (depth camera for patient positioning/size suggestion), and software-based DAP calculation. Image pasting function stitches sequential radiographs. Enhancements improve patient positioning, workflow efficiency, and exposure parameter management. Benefits include reduced manual effort for tube/table alignment and improved diagnostic image acquisition.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis, requirements/design reviews, module verification, system integration testing, performance/safety verification, and simulated use validation.

Technological Characteristics

Stationary X-ray system; 2-axis motorized tube stand; elevating table (max load 305kg); wireless 17x17 inch detectors (100um resolution); Siemens AL01CIIeL LED collimator; PSG-HR80S5 high voltage generator (50-80kW). Connectivity via DICOM 3.0 and 802.11 wireless. Software runs on Linux (SUSE).

Indications for Use

Indicated for digital radiographic imaging of skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Used in routine radiography exams with patient sitting, standing, or lying (prone/supine). Not for mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

Definium Pace Select (K231892)

Reference Devices

Discovery XR656 HD with VolumeRad (K191699)

Related Devices

K231892 — Definium Pace Select · Ge Hualun Medical Systems Co. , Ltd. · Sep 12, 2023
K250788 — Definium Tempo Select · Ge Hualun Medical Systems Co. , Ltd. · Aug 28, 2025
K140683 — 0180 INTUITION, 0072 PRECISION · Arcoma AB · Jun 3, 2014
K203345 — MULTIX Impact · Siemens Medical Solutions USA, Inc. · Jan 7, 2021
K070528 — PHILIPS ESSENTA DR · Philips Medical Systems GmbH, Dmc · Mar 9, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 1, 2024 GE Hualun Medical Systems Co., Ltd % Kenny Ma Manager, Regulatory Affairs - WHXR No.1, Yong Chang North Road, Beijing Economic Technological Development Zone Beijing, 100176 CHINA Re: K242678 Trade/Device Name: Definium Pace Select ET Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: September 3, 2024 Received: September 6, 2024 Dear Kenny Ma: 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}------------------------------------------------ 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 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 Radiologic 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 Submission Number (if known) K242678 Device Name Definium Pace Select ET ### Indications for Use (Describe) The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications. 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}------------------------------------------------ Image /page/4/Picture/2 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram enclosed in a circular design on the left, followed by the text "GE HealthCare" on the right. The text is in a simple, sans-serif font and is colored in the same shade of purple as the monogram. # 510K Summary Definium Pace Select ET {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in a matching purple color. The text is simple and modern. ## 510(k) Summary: In accordance with 21 CFR 807.92 the following summary information is provided: | Date: | September 6, 2024 | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner/Submitter: 21 CFR 807.92(a)(1) | GE Hualun Medical Systems Co., Ltd. No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, 100176 Beijing P.R. China | | Primary Contact Person: | Kenny Ma Manager, Regulatory Affairs, WHXR GE Hualun Medical Systems Co., Ltd. Email: Kenny.Ma@gehealthcare.com Contact Phone Number: +86 (181) 01130591 | | Secondary Contact Person: | Christopher Paulik Senior Regulatory Affairs Manager GE HealthCare (GE Medical Systems, LLC) Email: Christopher.A.Paulik@gehealthcare.com Contact Phone Number: +1 (262) 8945415 | | Device Trade Name: 21 CFR 801.92(a)(2) | Definium Pace Select ET | | Common/Usual Name: | Digital Radiographic System | | Regulation Name: | Stationary X-Ray System | | Regulation: | 21 CFR 892.1680 | | Classification: | Class II | | Product Code: | KPR | | Subsequent Product Code(s): | MQB | | Predicate Device: 21 CFR 807.92(a)(3) | Definium Pace Select (K231892) 21CFR 892.1680 (KPR, MQB) Class 2 | | Predicate Device Manufacturer | GE Hualun Medical Systems Co., Ltd. No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, 100176 Beijing P.R. China | | Reference Device: | Discovery XR656 HD with VolumeRad (K191699) 21CFR 892.1680 (KPR, MQB) Class 2 | | Reference Device Manufacturer: | GE Hualun Medical Systems Co., Ltd. No.1, Yong Chang North Road, Beijing Economic Technological Development Zone, 100176 Beijing P.R. China | | Device Description: 21 CFR 807.92(a)(4) | The Definium Pace Select ET Radiography X-ray System is designed as a modular system with components that include a 2-axis motorized tube stand with tube and auto collimator assembled on an elevating table, a motorized wall stand, a cabinet with X-ray high voltage generator, a wireless access point, wireless detectors, an acquisition workstation including a monitor and control box with hand-switch. The system generates diagnostic radiographic images which can be reviewed or managed locally and sent through a DICOM network for reviewing, storage and printing. By leveraging platform components / design, Definium Pace Select ET is similar to the predicate Definium Pace Select (K231892) and the reference Discovery XR656 HD (K191699) with regards to the user interface layout, patient worklist refresh and selection, protocol selection, image acquisition, and image processing based on the raw image. This product introduces motorized tube stand (vertical and tube angulation) instead of manual tube stand of the predicate. The high voltage generator is new and is backwards compatible to the predicates high voltage generator. This product also introduced Image Pasting on Table and Wall Stand Mode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAP software calculation, Siemens LED collimator and LCD touch screen console. The other minor changes include updates to components due to obsolescence. | | Indications for Use: 21 CFR 807.92(a)(5) | The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. | {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized "GE" monogram. The text "GE HealthCare" is also purple and is written in a clean, sans-serif font. are This device is not intended for mammographic applications. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE: 21CFR807.92(a)(6) A comparison of the indications for use and technological features of the subject and predicate device is provided in Table 1 below. | Specification | Predicate Device Definium Pace Select | Subject Device Definium Pace Select ET | Discussion of Differences | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | General Purpose Digital Radiographic Imaging System | General Purpose Digital Radiographic Imaging System | Identical | | Indications for Use | The Definium Pace Select is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be | The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be | Equivalent The optional image pasting function has been cleared in the reference product Discovery XR656 HD under K191699. | | Specification | Predicate Device Definium Pace Select | Subject Device Definium Pace Select ET | Discussion of Differences | | | performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. The device is not intended for mammographic applications. | performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. The device is not intended for mammographic applications. | | | Contraindications | None . | None . | Identical | | User group | Professional Use Only | Professional Use Only | Identical | | Patient Population | All ages | All ages | Identical | | System Software Architecture | Distributed software architecture (Atlas) | Distributed software architecture (Atlas) | Identical | | Operator I/F | One-LCD monitor, Keyboard, Mouse, Barcode reader | One-LCD monitor, Keyboard, Mouse, Barcode reader | Identical | | X-Ray Tube | Kailong 300kHU Tube: KL H1080Y | Kailong 300kHU Tube: KL H1080Y | Identical | | Tube head console | LED screen display | LCD touch screen console | Changed Besides the previous angle display. This console provides more positioner information and exposure parameter display and adjustment approach from the exam room. | | Collimator and Auto FOV | Manual collimator Manual FOV change and light on/off | Siemens AL01CIIeL LED lamp Manual and automatic FOV change and light on/off | Changed The device now provides additional automatic collimation (Auto FOV). | | DAP | Physical DAP meter | DAP software calculation based on FOV and SID measured by Encoder after Dose calibration | Changed The system now automatically calculates the DAP instead of providing a physical measurement. | | Specification | Predicate Device Definium Pace Select | Subject Device Definium Pace Select ET | Discussion of Differences | | Camera Workflow | None | The depth camera provides workflow improvement: 1. Live video on main UI 2. Patient size suggestion based on camera depth measurement; 3. Detector and ion chamber outline on video; 4. FOV adjustable from video | New This new feature provides additional observation for patient positioning. | | High Voltage Generator | - Jedi 80 RD 1T - 50KW or 65KW or 80kW | - PSG-HR80S5 - 50KW or 65KW or 80kW | Equivalent Same function, different supplier | | DICOM | DICOM 3.0 | DICOM 3.0 | Identical | | OS | Linux OS - SUSE | Linux OS - SUSE | Identical | | Detector | IRAY 17x17 detector US (K210314) | IRAY 17x17 detector US (K210314) | Identical | | Detector Wireless Connectivity | YES – 802.11 wireless (Personal Area Network) | YES – 802.11 wireless (Personal Area Network) | Identical | | Detector size/ resolution | One detector Size supported at 100 um resolutions: 17 x 17 inch | One detector Size supported at 100 um resolutions: 17 x 17 inch | Identical | | Detector loading | 300kg (distributed loading) 150kg (point loading) | 300kg (distributed loading) 150kg (point loading) | Identical | | Patient Table | Fixed table height 66cm 220 kg static non-elevating table Longitudinal travel 900mm Transversal travel 220mm | Elevating range 59 – 90 cm Maximum Loading 305kg (672lbs) Elevation speed< 18 seconds with loading 135kg(397lbs) Longitudinal travel 1110mm Transversal travel 220mm | Changed The table now provides motorized elevation with additional tabletop transverse and longitudinal travel range | | Tube Support | Floor-mount tube support with longitudinal vertical and angulation manual motion | Floor-mount tube support with longitudinal vertical and angulation manual motion. Additional motorization of vertical and angulation are provided | Changed The vertical and angulation motions are now motorized | | Tube to Table Tray Alignment | Alignment between tube stand and table tray is implemented by mechanical connection | Alignment between tube stand and table tray is implemented by automatic electrical control (also called auto alignment) | Equivalent Same function in tube and table tray alignment. | | Wall stand | Minimum height from floor to center of panel: 50cm Maximum height from floor to center of panel 176cm | Minimum height from floor to center of panel: 28.5 cm Maximum height from floor to center of panel 180.5 cm | Changed Motorized vertical travel with a minor | | Specification | Predicate Device Definium Pace Select | Subject Device Definium Pace Select ET | Discussion of Differences | | | Vertical travel 126cm No motorization | Vertical travel: 152 cm. Vertical motorization is provided | change in travel ranges. | | Image Pasting on Table and Wall Stand Mode | None | Image pasting can be performed at Wall stand mode and Table mode | New The image pasting function has been cleared in the reference product Discovery XR656 HD under K191699. | | Auto Grid Option | Yes Virtual grid function in Table, WS and DC mode | Yes Virtual grid function in Table, WS and DC mode | Identical | | Auto tracking for Wall Stand | None | Auto-tracking between Wall stand and tube stand vertically | New This feature is new to Predicate. But it is equivalent to the auto-tracking in the reference Discovery XR656 HD. | | Auto Angulation | None | Yes Tube can be automatically angulated according to the input on tube head console UI. | New The tube angulation is now motion controlled. | #### Table 1: High-level Comparison of Subject Device to Predicate {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the GE HealthCare logo. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The logo is purple in color. Page 4 of 7 {8}------------------------------------------------ Image /page/8/Picture/2 description: The image contains the logo for GE HealthCare. The logo consists of the GE monogram enclosed in a circular design on the left, followed by the text "GE HealthCare" in a sans-serif font. The color of the logo and text is a shade of purple. {9}------------------------------------------------ Image /page/9/Picture/2 description: The image contains the GE HealthCare logo. The logo consists of the GE monogram enclosed in a circular frame on the left, followed by the text "GE HealthCare" on the right. The color of the logo and text is a shade of purple. {10}------------------------------------------------ Image /page/10/Picture/2 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with intertwined letters on the left, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font. ## PERFORMANCE DATA: Determination of Substantial Equivalence 21 CFR807(b)(1) #### Summary of Non-Clinical Tests: The following quality assurance measures were applied to the development of Definium Pace Select ET system: - 1. Risk Analysis - 2. Requirements Reviews - 3. Design Reviews - 4. Testing on unit level (Module verification) - 5. Integration testing (System verification) - 6. Performance testing (Verification) - 7. Safety testing (Verification) - 8. Simulated use testing (Validation) Definium Pace Select ET verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results. #### Summary of Clinical testing: 21 CFR 807.92(b)(2) The Definium Pace Select ET does not contain clinical testing data. #### CONCLUSION: The results of the testing described above demonstrate that the Definium Pace Select ET is as safe and effective as the predicate device and supports a determination of substantial equivalence.