(30 days)
No
The description focuses on hardware components, integration of existing software, and replacement of parts. There is no mention of AI or ML algorithms for image analysis, diagnosis support, or other functions.
No
The device is used for obtaining diagnostic images, which aids in diagnosis rather than providing direct therapy.
Yes
The device's intended use explicitly states "obtaining diagnostic images to aid the physician with diagnosis." This directly indicates its role in the diagnostic process.
No
The device description explicitly lists multiple hardware components including x-ray generators, control panels, patient support tables, image receptors/detectors, tube supports, x-ray tube, collimator, circuit board, and a DAP meter. While it includes software (ImageView Software), it is an integral part of a larger hardware system.
Based on the provided text, the Q-Rad Radiographic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to obtain "diagnostic images to aid the physician with diagnosis" by performing "radiographic imaging of various portions of the human body." This involves imaging the human body directly, not testing samples taken from the body.
- Device Description: The device description details an X-ray system with components like generators, tables, detectors, and tubes. These are all components used for generating and capturing X-ray images of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD.
Therefore, the Q-Rad Radiographic System is a medical imaging device, specifically a radiographic system, and not an IVD.
N/A
Intended Use / Indications for Use
The Q-Rad Radiographic System is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography
Product codes
KPR, LLZ, MQB
Device Description
The Q-Rad System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, tube supports (ceiling-suspended or floormounted), x-ray tube, and collimator (beam-limiting device).
The Q-Rad System can be used with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.
The modified (subject) device is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:
- Integration of the FDA-Cleared ImageView Software (K163203) with the Q-Rad ● System.
- A circuit board (CIB+ Board) has been implemented on the Q-Rad System to ● facilitate a new communication protocol between the ImageView Software and the generator.
- The QMI (Quantum Medical Imaging) high voltage generator has been replaced with a Carestream-designed high voltage generator.
- The VacuTec Dose Area Product (DAP) meter Model 1560015 has been replaced ● with an equivalent DAP from a different supplier, the IBA Kermax plus with Ethernet interface 120-131 ETH (Standard Size).
- The Generator Control Box has been replaced. This control box is used to switch ● the generator on and off. Changes to the control box are cosmetic only and do not impact its functionality.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
skull, spinal column, extremities, chest, abdomen and other body parts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
The performance characteristics and operation / usability of the modified O-Rad System were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the system software requirements. Nonclinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.
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
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
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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.
January 22, 2020
Carestream Health, Inc. Carolyn Wagner Director Regulatory Affairs, Clearance & Surveillance Building 7, No. 1510 Chuanqiao Road CHINA (SHANGHAI) PILOT FREE TRADE ZONE, 201206 CN
Re: K193574
Trade/Device Name: Q-Rad System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, LLZ, MQB Dated: December 20, 2019 Received: December 23, 2019
Dear Carolyn Wagner:
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
1
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 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 (QS) 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 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-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,
Thalia Mills, Ph.D. Division Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K193574
Device Name Q-Rad System
Indications for Use (Describe)
The Q-Rad Radiographic System is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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Carestream
"510(k) Summary"
| 510(k) Owner Name: | Carestream Health, Inc. |
|---|---|
| 510(k) Owner Address: | 150 Verona Street |
| Rochester, NY, 14608 | |
| 510(k) Owner Phone: | 585-627-6505 |
| 510(k) Owner Fax: | 585-627-8802 |
| Contact Person & Info: | Carolyn L Wagner |
| Director Regulatory Affairs, Clearance & Surveillance | |
| carolyn.wagner@carestream.com | |
| 585-627-6588 |
Date Summary Prepared:
December 20, 2019
510(k) Submitter: Carestream Health, Inc. Trade Name: Q-Rad System Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system Review Panel: Radiology Product Code: KPR Regulation Number: 21 CFR 892.1680 Device Class: II
Predicate 510(k) Submitter: Quantum Medical Imaging Division of Carestream Health, Inc. Predicate Trade Name: Quantum / Canon CXDI Integration System, Model QG-DIG-Predicate 510(k) Number: K080905 Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system Review Panel: Radiology Product Code: LLZ; KPR; MQB Regulation Number: 21 CFR 892.2050 / 21 CFR 892.1680 / 21 CFR 892.1650 Device Class: II Device Description:
The Q-Rad System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image
4
receptors/detectors for upright imaging, tube supports (ceiling-suspended or floormounted), x-ray tube, and collimator (beam-limiting device).
The Q-Rad System can be used with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.
The modified (subject) device is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:
- Integration of the FDA-Cleared ImageView Software (K163203) with the Q-Rad ● System.
- A circuit board (CIB+ Board) has been implemented on the Q-Rad System to ● facilitate a new communication protocol between the ImageView Software and the generator.
- The QMI (Quantum Medical Imaging) high voltage generator has been replaced with a Carestream-designed high voltage generator.
- The VacuTec Dose Area Product (DAP) meter Model 1560015 has been replaced ● with an equivalent DAP from a different supplier, the IBA Kermax plus with Ethernet interface 120-131 ETH (Standard Size).
- The Generator Control Box has been replaced. This control box is used to switch ● the generator on and off. Changes to the control box are cosmetic only and do not impact its functionality.
Indications for Use / Intended Use:
The Indications for Use Statement for the O-Rad System (also sold under the brand name "DRX-Ascend System") as described in its labeling is:
"The Q-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography."
The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above.
The Indications for Use for the subject device is the identical to that of the predicate device and the intended use remains unchanged.
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Substantial Equivalence:
Based upon information provided within this submission, we believe that the modified Q-Rad System is substantially equivalent to the legally marketed Quantum / Canon CXDI Integration System, Model QG-DIG-CXDI (predicate device).
In accordance with FDA Final Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued July 28, 2014, the critical decision points outlined in the proposed 510(k) Decision-Making Flowchart in Appendix A have been considered. The proposed predicate device, Quantum / Canon CXDI Integration System. Model OG-DIG-CXDI. has been found substantially equivalent by FDA through the 510(k) process (K080905) and is legally marketed. The Indications for Use for the subject device are identical to the predicate indications and can therefore be considered for substantial equivalence.
Risk assessment of the modifications to the Q-Rad System described in this submission has not identified any new unmitigated risks for the system. Testing to recognized prevailing consensus standards and bench testing have indicated equivalent safety and performance of the modified device. We believe that the modifications to the Q-Rad System do not raise new issues of safety and effectiveness and therefore support a substantial equivalence determination.
Discussion of Testing
The performance characteristics and operation / usability of the modified O-Rad System were evaluated in non-clinical (bench) testing. These studies have demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the system software requirements. Nonclinical test results have demonstrated that the device conforms to its specifications. Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.