(58 days)
No
The document describes a standard digital radiography system and its components. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The image processing mentioned is likely standard digital image processing techniques, not AI/ML-based analysis.
No
The device is described as a "mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis," which indicates a diagnostic rather than therapeutic purpose.
Yes
The device description explicitly states, "uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology." Additionally, its intended use is "to acquire X-ray images of the human anatomy for medical diagnosis," and the acquired images are stated to be "sufficient for clinical diagnosis."
No
The device description explicitly lists multiple hardware components including a lifting column, system motion assembly, X-ray System (generator, tube, collimator, detectors), power supply system, and an Image Acquisition Workstation with a touchscreen. While it includes software, it is an integral part of a larger hardware system.
Based on the provided text, the uDR 380i Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for acquiring X-ray images of the human anatomy for medical diagnosis. This involves imaging the internal structures of the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a mobile X-ray system with components like an X-ray tube, generator, collimator, and flat panel detectors. These are all components of an imaging system, not a system for analyzing biological samples.
- 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 (head, chest, abdomen, etc.), which is consistent with an imaging device.
- No mention of analyzing biological samples: There is no mention of the device being used to test or analyze any type of biological sample.
In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, tissue, or urine, that have been taken from the human body to provide information for diagnosis, monitoring, or screening. The uDR 380i Pro does not perform this function.
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 K170332 and K192632), 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. The system offers:
- A 14"×17" or 14"×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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Electrical Safety and Electromagnetic Compatibility (EMC)
- Biocompatibility
- Software
- Other Standards and Guidance
- Performance Verification
Clinical Image Evaluation:
The clinical image evaluation was performed under the proposed device. 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.
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 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2022
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA
Re: K222339
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: July 30, 2022 Received: August 3, 2022
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 (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
1
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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of 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) K222339
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/3/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 symbol that resembles a "U" shape with a vertical line running through the center. The color of the logo is a dark teal or blue-green.
510 (k) SUMMARY
- Date of Preparation: 1. July 30, 2022
K222339
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 Position: Regulatory Affairs Manager 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
510(k) Number: K191025 Device Name: DRX-Revolution Mobile X-ray System Manufacturer: Carestream Health, Inc.
Regulatory Information
Classification Name: Mobile X-Ray System Classification: II Product Code: IZL Regulation Number: 21 CFR 892.1720 Review Panel: Radiology
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark teal font. To the right of the text is a stylized "U" shape, also in dark teal. The logo is simple and modern.
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 K170332 and K192632), 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. The system offers:
- A 14"×17" or 14"×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
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.
7. Comparison of Technological Characteristics with the Predicate Devices
A comparison between the technological characteristics of proposed and predicate devices is provided as below.
| ITEM | Predicate Device:
DRX-Revolution | 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
for Use | The device is designed to
perform radiographic x-ray
examinations on all
pediatric and adult patients,
in all patient treatment
areas. | 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 | Same | |
| | | and pediatric patient by a
qualified and trained
operator. This device is not | | |
| | | intended for
mammography. | | |
| Specifications | | | | |
| | High Voltage Generator | | | |
| Maximum
Output Power | 32kW | 32kw/ 50kW | Note 1 | |
| kV Range | 40150kV | 40150kV | Same | |
| mA Range | 25400 mA | 10400mA/ 10560mA | Note 2 | |+180° | -315°
| mAs Range | 0.1-320 mAs | 0.1-630 mAs | Note 3 | |
| | X-ray Tube | | | |
| Anode Heat
Content | 300kHU | 300kHU | Same | |
| Focus Size | 0.6mm/ 1.2mm | 0.6mm/ 1.2mm | 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 | 17" × 17"/ 14" × 17"/ 10" ×
12" | 14" × 17"/ 11" × 14" | Note 4 | |
| Scintillator
Material | Cesium Iodide | Cesium Iodide | Same | |
| Semiconducto
r Material | Amorphous Silicon | Amorphous Silicon | Same | |
| Pixel Size | 139µm | 125µm | Note 5 | |
| DQE | Typical:
63% @2.5uGy,0.5lp/mm | Typical:
58% @3uGy,0.5lp/mm | Note 6 | |
| MTF | Typical: 61% @ 1lp/mm
Typical: 32% @2lp/mm | Typical: 63% @ 1lp/mm
Typical: 35% @2lp/mm | Note 7 | |
| Anti-scatter Grid | | | | |
| Grid size | 350mm × 430mm | 356mm × 445mm | Note 8 | |
| Grid ratio | 8:1 | 8:1 | Same | |
| Telescoping Column | | | | |
| X-ray Tube
Assembly
RVA | -180°+315° | Note 9 | |+90° | -30°~+90° | Note 10 | |
| X-Ray Tube
Assembly
Tilting Range | -20°
| Max.
Distance
Between
Tube Focus
and Ground | 2058mm | 2000mm | Note 11 | |
| Min. Distance
Between
Tube Focus
and Ground | 724mm | 680mm | Note 12 | |
| Battery | | | | |
| Battery
Capacity | 2.88kWh | 2.40kWh | Note 13 | |
| Image Acquisition Workstation | | | | |
| Display Size | 19" | 19" | Same | |
| Disk Size | 500GB | 500GB | Same | |
| 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 AAMI
ES60601-1:2005 +C1;A2:
2012 | Comply with AAMI
ES60601-1:2005 +C1:A2:
2012 | Same | |
| EMC | Comply with IEC60601-1-
2:2014 | Comply with IEC60601-1-
2:2014 | Same | |
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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" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is 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 gray and has a white horizontal line through the middle.
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Image /page/7/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 teal in color and has a white vertical line running through the center.
| Biocompatibility | Comply with ISO10993-
5:2009 and ISO10993-
10:2010 | Comply with ISO10993-
5:2009 and ISO10993-
10:2010 | Same |
| ------------------ | ---------------------------------------------------------- | ---------------------------------------------------------- | ------ |
|---|
| Justification | ||
|---|---|---|
| Note 1 | The proposed device has two kinds of maximum output. One is same with | |
| the predict device, one is larger than the predict device. Larger maximum | ||
| output power represents better capability at generating higher mA or kV | ||
| level in X-ray. When operated under the intended use, increasing mA or kV | ||
| can achieve the same dose/signal level with shorter exposure time. The | ||
| difference did not raise new safety and effectiveness concerns. | ||
| Note 2 | The proposed device has two kinds of mA range. One is larger than the | |
| predict device. Larger mA range (10 | ||
| represents better capability at generating higher mA level in X-ray. When | ||
| operated under the intended use, increasing mA can achieve the same | ||
| dose/signal level with shorter exposure time. The difference did not raise | ||
| new safety and effectiveness concerns. | ||
| Note 3 | The proposed device has a larger mAs Range than the predict device. Larger | |
| mAs Range can meet the clinical demand for high dose exposure of people | ||
| with larger body thickness. The different range of mAs did not raise new | ||
| safety and effectiveness concerns. | ||
| Note 4 | The proposed device does not have a 17" x 17" detector. However, the | |
| 14*17 board can cover any parts that need to be inspected, and it is also a | ||
| size commonly used in clinical practice. The 11" x 14" detector size is | ||
| larger than 10" x 12", which allows it to better cover all detection needs of | ||
| the infant. In addition, the 11" x 14" detector can meet the size of the crib. | ||
| The different size of detector did not raise new safety and effectiveness | ||
| concerns. | ||
| Note 5 | The pixel size of the proposed device is smaller than that of the predict | |
| device. Smaller pixel size, better capability at generating higher spatial | ||
| resolution X-ray images. The different pixel size of detector did not raise | ||
| new safety and effectiveness concerns. | ||
| Note 6 | DQE of the proposed device and predict device was test under different | |
| condition. Performance is similar. When operated under the intended use, it | ||
| did not raise new safety and effectiveness concerns. | ||
| Note 7 | MTF of the proposed device is better than that of the predict device. When operated under the intended use, it did not raise new safety and effectiveness concerns. | |
| Note 8 | The grid size of the proposed device is larger than that of the predict device and can fully cover its detector. When operated under the intended use, it did not raise new safety and effectiveness concerns. | |
| Note 9 | The X-ray tube assembly RVA range of the proposed device is larger than that of the predict device. Larger range, better X-ray tube assembly positioning capability. When operated under the intended use, it did not raise new safety and effectiveness concerns. | |
| Note 10 | The X-ray tube assembly tilting range of the proposed device is larger than that of the predict device. Larger range, better X-ray tube assembly positioning capability. When operated under the intended use, it did not raise new safety and effectiveness concerns. | |
| Note 11 | The maximum distance between the tube focus and ground of the proposed device is shorter than that of the predict device, however the height can satisfy its intended use. So it did not raise new safety and effectiveness concerns. | |
| Note 12 | The minimum distance between the tube focus and ground of the proposed device is shorter than that of the predict device. Shorter distance, better X-ray tube assembly positioning capability. When operated under the intended use, it did not raise new safety and effectiveness concerns. | |
| Note 13 | The battery capacity of the proposed device is lower than that of the predict device. However, it can satisfy the requirement of clinical use, thus it did not raise new safety and effectiveness concerns. |
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Image /page/8/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 also in a bold, sans-serif font. The color of the text and the "U" symbol is a dark teal.
8. Performance Date
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:
Electrical Safety and Electromagnetic Compatibility (EMC)
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A A2:2010/(R)2012, Medical electric for basic safety and essential performance
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Image /page/9/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" shape, which is dark gray. The logo is simple and modern in design.
(IEC 60601-1:2005, MOD).
- IEC 60601-1-2: 2014, Edition 4.0, Medical electrical equipment Part 1-2: A General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- A IEC 60601-1-3: 2008+AMD1:2013, Edition 2.1, 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: 2009 +A1:2015+A2:2018, Edition 1.2, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
-
IEC 60825-1: 2007+COR1:2008, Edition 2.0, Safety of laser products - Part 1: Equipment classification and requirements.IEC 60601-1-6:2010+A1:2013, Edition 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
-
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
- A IEC 62304: 2006+A1:2015, Edition 1.1, Medical device software - Software life cycle processes.
Biocompatibility
- A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
-
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(2016): Digital Imaging and Communications in Medicine (DICOM)
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Other Standards and Guidance
- A ISO 14971: Medical Devices - Application of risk management to medical devices
- A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
- A FDA guidance, Pediatric Information for X-ray Imaging Device Premarket Notifications.
Performance Verification
- Code of Federal Regulations, Title 21, Part 1020 Performance standards for A
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Image /page/10/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 symbol that resembles a shield or a letter "U" with a vertical line running through the center, creating a negative space "I" shape. The color of the text and symbol is a dark teal or blue-gray.
ionizing radiation emitting products
Clinical Image Evaluation
The clinical image evaluation was performed under the proposed device. 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.
9. Conclusions
Based on the comparison and analysis above, the proposed device uDR 380i Pro has the equivalent intended use, safety and effectiveness as the predicate device Carestream DRX-Revolution. The differences in technical specifications between the proposed device and the predicate devices do not negatively affect the system's safety and effectiveness. The proposed device uDR 380i Pro is determined to be Substantially Equivalent (SE) to the predicate device Carestream DRX-Revolution.