(48 days)
No
The document describes standard digital radiography technology and image processing, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or specific AI-driven image analysis features. The performance studies focus on image quality evaluation by a radiologist, not on the performance of an AI/ML algorithm.
No.
The device is described as a "mobile digital radiography device intended to acquire X-ray images... for medical diagnosis," and a "diagnostic mobile x-ray system." Its purpose is to acquire images for diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to acquire X-ray images of the human anatomy for medical diagnosis," and the "Device Description" section describes it as a "diagnostic mobile x-ray system."
No
The device description explicitly states it "mainly consists of a lifting column - telescopic cantilever frame system, system motion assembly, X-ray System (high voltage generator, x-ray tube, collimator and wireless flat panel detectors...), power supply system and software". This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring X-ray images of the human anatomy for medical diagnosis. This is a function of medical imaging, not in vitro diagnostics.
- Device Description: The description details a mobile X-ray system, including components like an X-ray tube, generator, collimator, and detectors. These are all components of an imaging system, not a device used to test samples outside the body.
- Input Imaging Modality: The input modality is X-ray, which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The device is used on the human anatomy, meaning it interacts directly with the patient's body to produce images. IVDs analyze samples taken from the body (like blood, urine, tissue).
In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests. It is a medical imaging device.
N/A
Intended Use / Indications for Use
uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.
Product codes
IZL
Device Description
uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. It can be moved to different environments for an examination, like emergency room. ICU and ward. It mainly consists of a lifting column - telescopic cantilever frame system, system motion assembly, X-ray System (high voltage generator, x-ray tube, collimator and wireless flat panel detectors which have been cleared in K230175), power supply system and software for acquiring and processing the clinical images. uDR 380i Pro is intended to acquire X-ray images for both adult and pediatric, especially for person who may not be able to be moved to a traditional RAD room. uDR 380i Pro have been previously cleared by FDA via K222339. The system offers: A 14"×17" or 11"×14" flat panel detector, A high-power, 32 kW or 50kW generator, A maneuverable drive system, X-ray tube-collimator assembly with flexible movement, Storage for detectors and supplies, Image Acquisition Workstation with touchscreen user interface.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adult and pediatric patient
Intended User / Care Setting
qualified and trained operator / emergency room, ICU and ward
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The clinical image evaluation was performed under the proposed device with CXDI-710C. Sample image of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Image Evaluation: Sample images of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were reviewed by a board certified radiologist. Key results: "Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 & Human Services logo. To the right of that is the FDA logo, which 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 10, 2024
Shanghai United Imaging Healthcare Co.,Ltd. % Xin Gao Regulatory Affairs Manager No.2258 Chengbei Rd. Jiading District Shanghai, 201807 CHINA
Re: K242515
Trade/Device Name: uDR 380i Pro Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: August 21, 2024 Received: August 23, 2024
Dear Xin Gao:
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 medical devices and radiation-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-devices/device
2
advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242515
Device Name uDR 380i Pro
Indications for Use (Describe)
uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended 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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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark gray.
510 (k) SUMMARY
1. Date of Preparation:
August 23, 2024
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: 3011015597
Contact Person: Xin GAO Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uDR 380i Pro Common Name: Mobile Digital Medical X-ray Imaging System Model(s): uDR 380i Pro
Regulatory Information
Classification Name: Mobile X-Ray System Classification: II Product Code: IZL Regulation Number: 21 CFR 892.1720 Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device
Trade Name: uDR 380i Pro 510(k) Number: K222339 Device Name: Mobile Digital Medical X-ray Imaging System Manufacturer:Shanghai United Imaging Healthcare Co.,Ltd.
Regulatory Information
Classification Name: Mobile X-Ray System Classification: II Product Code: IZL Regulation Number: 21 CFR 892.1720 Review Panel: Radiology
Page 1 of 6
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark blue and has a white vertical line running through the center. The logo is simple and modern in design.
5. Device Description
uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. It can be moved to different environments for an examination, like emergency room. ICU and ward. It mainly consists of a lifting column - telescopic cantilever frame system, system motion assembly, X-ray System (high voltage generator, x-ray tube, collimator and wireless flat panel detectors which have been cleared in K230175), power supply system and software for acquiring and processing the clinical images.
uDR 380i Pro is intended to acquire X-ray images for both adult and pediatric, especially for person who may not be able to be moved to a traditional RAD room. uDR 380i Pro have been previously cleared by FDA via K222339.
The system offers:
- A 14"×17" or 11"×14" flat panel detector
- A high-power, 32 kW or 50kW generator
- A maneuverable drive system
- X-ray tube-collimator assembly with flexible movement
- . Storage for detectors and supplies
- . Image Acquisition Workstation with touchscreen user interface
The modifications performed on the uDR 380i Pro (K222339) in this submission are due to the addition of flat panel detectors, including CXDI-710C and CXDI-810C, and CXDI Control Software NE which were cleared in K230175.
The device software is unchanged from the predicate device, except for the addition of CXDI Control Software NE.
The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device.
6. Indications for use
uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" symbol. The symbol is a dark gray color and has a white line running vertically through the center.
7. Comparison of Technological Characteristics with the Predicate Devices
A comparison between the technological characteristics of proposed and predicate devices is provided as below.
| Table 1 Comparison of Technology Characteristics | |||
|---|---|---|---|
| ITEM | Predicate Device: | ||
| uDR 380i Pro | |||
| K222339 | Proposed Device: | ||
| uDR 380i Pro | Remark | ||
| Product Code | IZL | IZL | Same |
| Regulation | |||
| No. | 21 CFR 892.1720 | 21 CFR 892.1720 | Same |
| Class | II | II | Same |
| Indications | |||
| Use | uDR 380i Pro is a mobile | ||
| digital radiography device | |||
| intended to acquire X-ray | |||
| images of the human | |||
| anatomy for medical | |||
| diagnosis. uDR 380i Pro | |||
| can be used on both adult | |||
| and pediatric patient by a | |||
| qualified and trained | |||
| operator. This device is not | |||
| intended for | |||
| mammography. | uDR 380i Pro is a mobile | ||
| digital radiography device | |||
| intended to acquire X-ray | |||
| images of the human | |||
| anatomy for medical | |||
| diagnosis. uDR 380i Pro can | |||
| be used on both adult and | |||
| pediatric patient by a | |||
| qualified and trained | |||
| operator. This device is not | |||
| intended for mammography. | Same | ||
| Specifications | High Voltage Generator | ||
| Maximum | |||
| Output Power | 32kw/ 50kW | 32kw/ 50kW | Same |
| kV Range | 40~150kV | 40~150kV | Same |
| mA Range | 10 | 10 | Same |
| mAs Range | 0.1-630 mAs | 0.1-630 mAs | Same |
| X-ray Tube | |||
| Anode Heat | |||
| Content | 300KHU | 300kHU | Same |
| Focus Size | 0.6/ 1.2 | 0.6/1.2 | Same |
| Anode Target | |||
| Angle | 14° | 14° | Same |
| Collimator | |||
| Maximum | |||
| Light Field | 43cm × 43cm | 43cm × 43cm | Same |
| Adjustment | |||
| Method | Manual | Manual | Same |
| Flat Panel Detector | |||
| Detector Size | 14" × 17"/ 11" × 14" | 14" × 17"/ 11" × 14" | Same |
| Scintillator | |||
| Material | Cesium Iodide | Cesium Iodide | Same |
| Semiconducto | |||
| r Material | Amorphous Silicon | Amorphous Silicon | Same |
| Pixel Size | 125μm | 125μm | Same |
| DQE | Typical: | ||
| 58% @3uGy,0.5lp/mm | Typical: | ||
| 0.58±10% @3uGy,0.5lp/mm | |||
| (for AR-C3543W&AR- | |||
| B2735W) | |||
| Typical:0.58±10% @2.5uGy | |||
| ,0.5lp/mm (for CXDI-710C | |||
| & CXDI-810C) | Note 1 | ||
| MTF | Typical: 63% @ 1lp/mm | ||
| Typical: 35% @2lp/mm | Typical: 63% @ 1lp/mm | ||
| Typical: 35% @2lp/mm | Same | ||
| Anti-scatter Grid | |||
| Grid size | 356mm × 445mm | 356mm × 445mm | Same |
| Grid ratio | 8:1 | 8:1 | Same |
| Telescoping Column | |||
| X-ray Tube | |||
| Assembly | |||
| RVA | -315 $^{\circ}$ ~+315 $^{\circ}$ | -315 $^{\circ}$ ~+315 $^{\circ}$ | Same |
| X-Ray Tube | |||
| Assembly | |||
| Tilting Range | -30 $^{\circ}$ ~+90 $^{\circ}$ | -30 $^{\circ}$ ~+90 $^{\circ}$ | Same |
| Battery | |||
| Battery | |||
| Capacity | 2.40kWh | 2.40kWh | Same |
| Image Acquisition Workstation | |||
| Display Size | 19" | 19" | Same |
| Disk Size | 500GB | ≥500GB | Note 2 |
| Software function | |||
| Image | |||
| Export/Import | Yes | Yes | Same |
| Image | |||
| Viewing | Yes | Yes | Same |
| Image | |||
| Measurement | Yes | Yes | Same |
| Image | |||
| Annotation | Yes | Yes | Same |
| Image Post- | |||
| processing | Yes | Yes | Same |
| Virtual grid | Yes | Yes | Same |
| Accessory | |||
| Badge Reader | Yes | Yes | Same |
| Safety | |||
| Electrical Safety | Comply with ANSI/AAMI ES 60601-1 | Comply with ANSI/AAMI ES 60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Biocompatibility | Comply with ISO10993-5 and ISO10993-10 | Comply with ISO10993-5 and ISO10993-10 | Same |
Table 1 Comparison of Technology Characteristics
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark blue font and is stacked on top of each other. To the right of the text is a dark blue emblem that resembles the letter "U" with a horizontal line through the middle.
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is bisected by a vertical line and has a horizontal line across the middle. The logo is simple and modern.
| Justification | |
|---|---|
| Note ID | Justification |
| Note 1 | DQE Performance is similar. When operated under the intended use, it did not raise new safety and effectiveness concerns. |
| Note 2 | The disk size of the proposed device is actually a range value, which is only a descriptive update, however the disk size can satisfy its intended use. So it did not raise new safety and effectiveness concerns. |
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
- ANSI/AAMI ES60601-1:2005& A1:2012 & A2:2021 Medical electric for basic > safety and essential performance.
- IEC 60601-1-2: 2014+AMD1: 2020,Edition 4.1,Medical electrical > equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- A IEC 60601-1-3: 2008+AMD1: 2013+AMD2: 2021,Edition 2.2, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- A IEC 60601-2-54: 2022, Edition 2.0, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
-
IEC 60601-1-6:2010+AMD1:2013+AMD2: 2020, Editon 3.2, Medical electrical
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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark blue font. To the right of the text is a stylized dark blue symbol that resembles the letter "U" with a white horizontal line through the middle.
equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
-
IEC 62366-1: 2015+AMD1: 2020, Edition 1.1, Medical devices - Part 1: Application of usability engineering to medical devices
- A IEC 62304: 2006+AMD1:2015, Edition 1.1, Medical device software - Software life cycle processes.
- A IEC TS 60601 -4-2:2024 Edition 1.0, Medical electrical equipment - Part 4-2: Guidance a and interpretation- Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
Biocompatibility
- A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- A ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization.
Software
-
NEMA PS 3.1-3.20(2022): Digital Imaging and Communications in Medicine (DICOM)
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Clinical Image Evaluation
The clinical image evaluation was performed under the proposed device with CXDI-710C. Sample image of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis.
Summarv
The features described in this premarket submission are supported with the results of the testing mentioned above, the uDR 380i Pro was found to have a safety and effectiveness profile that is similar to the predicate device.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device has same indications for use, similar performance, equivalence safety and effectiveness as the predicate device.
The differences above between the proposed device and predicate device do not affect the indications for use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.
The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.