(196 days)
No
The summary describes standard digital image processing ("SNC image output") and comparison testing based on pixel values and noise ratios, which are not indicative of AI/ML. There is no mention of AI, ML, or related terms, nor is there a description of training or test sets typical for AI/ML models.
No
The device is described as a "mobile diagnostic x-ray system" used for "acquiring and processing medical diagnostic images," which means it focuses on diagnosis rather than providing therapy.
Yes
The device description explicitly states, "The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system" and "[i]t is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions." Additionally, the "Intended Use" mentions "radiographic x-ray examinations," which are a form of diagnostic imaging.
No
The device description explicitly states it is a "mobile diagnostic x-ray system" with key hardware components including an x-ray generator, tube head assembly, drive system, and touchscreen user interface. While it includes software for image acquisition and processing, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that the device is a "mobile diagnostic x-ray system" that "generates and controls X-rays for examination of various anatomical regions." This involves using radiation to create images of the inside of the body, not analyzing samples taken from the body.
- Intended Use: The intended use is to "perform radiographic x-ray examinations," which is a form of medical imaging, not in vitro testing.
The device is a medical imaging device, specifically a mobile X-ray system.
N/A
Intended Use / Indications for Use
"The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas."
Product codes (comma separated list FDA assigned to the subject device)
IZL
Device Description
The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all pediatric and adult patients
Intended User / Care Setting
Not Found
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)
Clinical testing was not required to establish substantial equivalence. Performance testing was sufficient to assess the device safety and effectiveness and to demonstrate that the modified device is substantially equivalent to the cleared device.
Comparison testing was performed to demonstrate SNC image output is the same on the mobile system as it is on the in-room system (K202441). A pixel-by-pixel analysis was used to determine whether the SNC processing performed on the DRX-Revolution Mobile X-ray system is considered equivalent to the SNC processing performed on the DRX-Evolution Plus system. The processed images on both systems were visually compared on a diagnostic monitor using flicker comparison (fast switching of registered images to detect small differences) and no perceptible differences were observed when compared at 200% magnification. The results of the SNC images demonstrated that at least 99% of all image pixels were within ± 1 pixel value. All pixels in the output image must be within +/-1 pixel value and the absolute maximum difference seen across all the test images was 3-pixel values, thus meeting the acceptance criteria of a maximum allowable difference of 10-pixel values.
Additionally, a noise ratio metric was created to compare the SNC noise field difference with the expected system noise variation. All noise ratio values computed for every pixel of the test images were less than 1.0 indicating that the difference in SNC noise fields between the Evolution and Revolution systems was less than the expected system noise, further supporting the conclusion that the SNC image differences on the mobile system are undetectable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K163203, K223842, K150766, K153142, K183245, K203159, K202441
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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 acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.
December 10, 2024
Carestream Health Inc. % Gina Maiolo Sr. Regulatory Affairs Manager 150 Verona St. ROCHESTER, NY 14608
Re: K241505
Trade/Device Name: DRX-Revolution Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: November 12, 2024 Received: November 12, 2024
Dear Gina Maiolo:
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-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)
Device Name
DRX-Revolution Mobile X-ray System
Indications for Use (Describe)
"The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas."
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/0 description: The image shows the word "Carestream" in orange font. The font is sans-serif and appears to be bolded. The word is horizontally oriented and centered in the image.
510(k) Summary
510(k) Owner Name
Carestream Health, Inc.
510(k) Owner Address 150 Verona Street Rochester, New York 14608 510(k) Owner Contact Information Gina Maiolo Regulatory Affairs Manager Phone (Mobile) 516.395.0597 Date Summary Prepared October 28 2024 Device Trade Name DRX-Revolution Mobile X-Ray System Device Common Name Mobile System Classification Name Mobile X-ray system Device Class Class II Device Code IZL Regulation Number 21 CFR 892.1720. Predicate Device DRX-Revolution Mobile X-Ray System (K191025)
Carestream Health, Inc. is submitting this Traditional 510(k) premarket notifications to the DRX-Revolution System. Carestream believes that the modified device is substantially equivalent to the cleared device (K191025).
Indications for Use
"The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas".
Device Description
The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.
5
restream
Technological Characteristics
The modified DRX-Revolution Mobile X-ray system is substantially equivalent to the predicate device currently cleared on the market (K191025).
- The modified DRX-Revolution consists of the same fundamental scientific technology and is . designed with the same operating principles as the predicate device. The predicate and modified device consist of the same critical components: an x-ray generator, x-ray tube, collimator, and image acquisition software (ImageView) to support image / patient management.
- . The digital radiography application software has been cleared for use across the following Carestream digital radiography devices: DRX-Evolution System (K163203), DRX-Compass System (K223842), DRX-Revolution (K191025).
- . The ImageView software is the same image acquisition software installed on the predicate device (K191025). Eclipse II, the image processing software (designed into ImageView) and the imaging processing components cleared on the predicate device are the same on the modified device. The predicate was cleared with ImageView V1.0 and the modified device will run ImageView V2.0. The difference in versions do not raise additional question on safety or performance. The below key functionality offered in V2.0 is the same on the cleared device.
- · Configuration of operational parameters
- · Patient creation
- · Patient worklist
- · Status Display (acquisition, delivery, errors, etc.)
- · X-Ray Generator operation
- · Image acquisition
- · Image review
- · Communication to external HIS, RIS, PACS, and printers
- The modified DRX-Revolution system is compatible with the following legally marketed Carestream detectors (same detectors cleared with the predicate device): DRX Plus 3543C (K150766), DRX Plus 4343C (K153142), DRX Plus 2530C (K183245).
- . The Lux 35 detector is an additional detector that will be available for sale with the DRX-Revolution. Lux 35 was cleared (K203159) in a separate submission and is determined substantially equivalent to the DRX Plus detectors as the MTF/DQE data demonstrates.
- . Smart Noise Cancellation (SNC) on the mobile x-ray system produces the same image output as the in-room x-ray system (with SNC). Comparison testing was performed and demonstrates imaging output and performance on the mobile system is the same as it is on the in-room system.
Comparison of Technological Characteristics
A comparison chart provides the similarities and differences between the modified and predicate devices.
| Predicate Device | Subject Device | Comments | |
|---|---|---|---|
| Device Name | DRX-Revolution Mobile X- | ||
| ray System | DRX-Revolution Mobile | ||
| X-ray System | |||
| 510(k) Number | K191025 | K241505 | |
| Device Classification | |||
| Name | Mobile X-ray System | Mobile X-ray System | |
| Intended Use | The device is designed to | ||
| perform radiographic x-ray | |||
| examinations on all pediatric | |||
| and adult patients, in all | |||
| patient treatment areas. | Same | No impact | |
| X-ray Generator | |||
| Model/Rating | Carestream Generator (32kW) | Same | No impact |
| X-ray Tube | |||
| Manufacture/Model | Toshiba/XRR-3336X | Same | No impact |
| Image Processing | |||
| Software | Eclipse II | Same | No impact |
| DR Application System | |||
| Software | ImageView Software | Same | No impact |
| Smart Noise | |||
| Cancellation (SNC) | No | Yes | SNC is cleared with a stationary |
| x-ray system (DRX Evolution - | |||
| K202441). SNC functions the | |||
| same on the DRX-Revolution | |||
| system (mobile) as it does on | |||
| the DRX-Evolution (in-room) | |||
| system. | |||
| Comparison testing shows SNC | |||
| image output is the same on the | |||
| mobile system as it is on the | |||
| cleared in-room system | |||
| (K202441). | |||
| Supplemental data demonstrates | |||
| the testing for Smart Noise | |||
| Cancellation (SNC) on the | |||
| DRX-Revolution (mobile | |||
| system) is comprehensive and | |||
| the functionality was adequately | |||
| tested. | |||
| Digital Flat Panel | |||
| Detectors | DRX Plus 3543C, 4343C | ||
| (K153142) | |||
| DRX Plus 2530C (K183245) | Same | ||
| Lux 35 Detector | |||
| (K203159) | Lux 35 obtained clearance in a | ||
| separate submission K203159. | |||
| Addition of a detector has no | |||
| impact on image quality or on | |||
| the imaging system. Lux 35 is | |||
| substantially equivalent to the | |||
| DRX Plus detectors. | |||
| System integration testing was | |||
| performed to support integration | |||
| of the compatible detectors with | |||
| the DRX-Revolution system | |||
| using ImageView Software | |||
| v2.0. | |||
| Align Assist | No | Yes | Improvement to optimize |
| workflow operation. | |||
| Inching | No | Yes | Additional option for movement |
| of the cart. | |||
| Verification and validation | |||
| testing of both hardware and | |||
| software were completed to | |||
| demonstrate safety and | |||
| performance. | |||
| Cumulative Changes | Yes | Yes | Design improvements to |
| components (component-level | |||
| functionality same on predicate) | |||
| • Generator components | |||
| • Tube head handles | |||
| • Tube head covers | |||
| • Cord Reel |
6
Image /page/6/Picture/0 description: The image shows the word "Carestream" in a sans-serif font. The word is written in orange color. The letters are closely spaced, giving the word a compact appearance.
7
Carestream
8
arestream
Summary of Non-Clinical Testing
Clinical testing was not required to establish substantial equivalence. Performance testing was sufficient to assess the device safety and effectiveness and to demonstrate that the modified device is substantially equivalent to the cleared device.
Comparison testing was performed to demonstrate SNC image output is the same on the mobile system as it is on the in-room system (K202441). A pixel-by-pixel analysis was used to determine whether the SNC processing performed on the DRX-Revolution Mobile X-ray system is considered equivalent to the SNC processing performed on the DRX-Evolution Plus system. The processed images on both systems were visually compared on a diagnostic monitor using flicker comparison (fast switching of registered images to detect small differences) and no perceptible differences were observed when compared at 200% magnification. The results of the SNC images demonstrated that at least 99% of all image pixels were within ± 1 pixel value. All pixels in the output image must be within +/-1 pixel value and the absolute maximum difference seen across all the test images was 3-pixel values, thus meeting the acceptance criteria of a maximum allowable difference of 10-pixel values.
Additionally, a noise ratio metric was created to compare the SNC noise field difference with the expected system noise variation. All noise ratio values computed for every pixel of the test images were less than 1.0 indicating that the difference in SNC noise fields between the Evolution and Revolution systems was less than the expected system noise, further supporting the conclusion that the SNC image differences on the mobile system are undetectable.
The following consensus standards were met:
- ISO 14971:2019 Application of risk management to medical devices
- ISO 20471:2021 Medical devices - Information to be supplied by the manufacturer
- IEC 62366-1:2015+A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
- . ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- . AAMI ES60601-1:2005 +C1:A2: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012)
- IEC 60601-1-2:2015 Electro-Magnetic Compatibility including FCC Part 15 Subpart B:2018
- . IEC 60601-1-3:2008+A2:2021 (Second Edition) + A1:2013 Medical electrical equipment - Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
- . IEC 60601-1-6:2010 + A1:2015, Edition 3.0 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard
- . IEC 60601-2-54:2009+A1:2015 Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- . 60601-2-28:2017 Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
- . IEC 62304:2006 + A1:2015 Medical device software life-cycle processes
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a . risk management process
- Digital Imaging and Communication in Medicine (DICOM) .