(55 days)
No
The summary describes a digital X-ray system with a flat panel detector and remote control capabilities. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the hardware and basic image acquisition and display.
No
This device is an imaging system designed to generate fluoroscopic images for diagnostic and interventional procedures, not to provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "diagnostic" procedures in both vascular angiography and cardiology.
No
The device description clearly outlines hardware components such as a Flat Panel Detector (FPD), a tilting/elevating table, and a control console, indicating it is a physical system, not software-only.
Based on the provided information, 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 about a person's health.
- Device Function: The D2RS & D2RS9090 system is an imaging device that uses X-rays to generate images of the internal structure of the human body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is for generating fluoroscopic images of human anatomy for diagnostic and interventional procedures. This is a form of medical imaging, not in vitro testing.
- Device Description: The description details the components and function of an X-ray imaging system, including a flat panel detector and a tilting table. This aligns with imaging technology, not IVD technology.
Therefore, the D2RS & D2RS9090 Digital Dynamic Remote System is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Product codes
OWB, JAA, IZI
Device Description
As compared to the predicate system, we have added a newer model Canon Digital Dynamic X-ray receptor panel, model: CXDI-RF Wireless B1. The original Canon panel remains available. System components and the "look" of the system have been updated and modernized. The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. Panel information: Based on a flat-panel digital detector with the largest field-of-view in the market, the CANON CXDI-RF Wireless B1 is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an all-digital real-time system, generating high-quality images for both routine dynamic applications and high-end static ones. Digital technology facilitates the work of X-ray technicians and speeds up the process, allowing medical centers to optimize patient throughput. Universal: a single detector for both Radiography or Fluoroscopy. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, X-ray technicians
Inside a patient environment.
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)
Bench/Performance Testing Data: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.) Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. For the new digital x-ray panel we provided testing according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Druq Administration Staff.
Clinical Evaluation: As required by the FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff. A board certified radiologist reviewed both static and moving images and found them to be of excellent diagnostic quality.
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.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is 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.
December 23, 2021
Stephanix % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES, FL 34114
Re: K213479
Trade/Device Name: D2RS and D2RS 9090 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: October 28, 2021 Received: October 29, 2021
Dear Daniel Kamm:
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,
for
Thalia T. Mills, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K213479
Device Name D2RS & D2RS9090 Digital Dynamic Remote System
Indications for Use (Describe)
D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Stephanix Radiological Systems Rue Jean Moulin - ZI du Bayon La Ricamarie - FRANCE Tel : + 33 4 77 47 81 60 Fax : + 33 4 77 37 55 19 D2RS & D2RS9090 Digital Dynamic Remote System
Date Prepared: October 28, 2021 Summary prepared by: Sandie Perret, Quality Manager
-
- Trade/Device Name: D2RS & D2RS9090 Digital Dynamic Remote System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB,, JAA, IZI
-
- Identification of Predicate Device: K102529 Manufacturer: Stephanix Radiological Systems Trade/Device Name: D2RF Digital Dynamic Remote System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB,, JAA, IZI
-
- Device Description: As compared to the predicate system, we have added a newer model Canon Digital Dynamic X-ray receptor panel, model: CXDI-RF Wireless B1. The original Canon panel remains available. System components and the "look" of the system have been updated and modernized. The D2RS & D2RS9090 are direct digital dynamic remote-controlled fluoroscopy and radiography systems equipped with the latest generation of Canon Flat Panel Detector (FPD). The single FPD can perform both fluoroscopy and radiography and is detachable and portable for direct projections to create a unique and highly versatile 3-in-1 imaging solution. The receptor panel directly converts the X-ray images captured by the sensor into a high-resolution digital images. The instrument is suited for use inside a patient environment. This unit converts the X-rays into digital signals. The unit can acquire still and moving images. The system includes a remotely controlled tilting/elevating table. Panel information: Based on a flat-panel digital detector with the largest field-of-view in the market, the CANON CXDI-RF Wireless B1 is designed for easy integration in classical R&F tables. It allows manufacturers to offer radiologists an all-digital real-time system, generating high-quality images for both routine dynamic applications and high-end static ones. Digital technology facilitates the work of X-ray technicians and speeds up the process, allowing medical centers to optimize patient throughput. Universal: a single detector for both Radiography or Fluoroscopy. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous
4
version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version). The control console has been updated to a more modern looking design but is functionally identical to the predicate.
-
- Indications for Use: The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
-
- Technological Characteristics and Substantial Equivalence Comparison with the predicate shows the technological characteristics of the modified devices are equal to or better than the predicate device. Please see the detailed comparison table below. The units are functionally identical. Only the digital panel has changed. The new panel is the CANON CXDI-RF Wireless B1. A new tilting table has been introduced (D2RS9090). This new variant of D2RS consists of a modification of the foot of the remote controlled table. Instead of being down the table, this one is now behind. This allows a tilting from -90 to +90° (versus -25 to 90° with previous version) and an elevation from 368 to 1455 cm (versus 640 to 930 cm with previous version).
| Comparison Table | ||
|---|---|---|
| D2RF Digital Dynamic Remote System | ||
| K102529 | D2RS & D2RS9090 Digital Dynamic Remote | |
| System | ||
| Indications | ||
| Statement | The D2RS Digital Dynamic Remote System is | |
| indicated for use in generating fluoroscopic | ||
| images of human anatomy for vascular | ||
| angiography, diagnostic, and interventional | ||
| procedures. It is also indicated for generating | ||
| fluoroscopic images of human anatomy for | ||
| cardiology, diagnostic, and interventional | ||
| procedures. It is intended to replace | ||
| fluoroscopic images obtained through image | ||
| intensifier technology. Not intended for | ||
| mammography applications. | D2RS & D2RS9090 Digital Dynamic Remote | |
| System is indicated for use in generating | ||
| fluoroscopic images of human anatomy for | ||
| vascular angiography, diagnostic, and | ||
| interventional procedures. It is also indicated | ||
| for generating fluoroscopic images of human | ||
| anatomy for cardiology, diagnostic, and | ||
| interventional procedures. It is intended to | ||
| replace fluoroscopic images obtained through | ||
| image intensifier technology. Not intended for | ||
| mammography applications. SAME THE | ||
| INDICATIONS FOR USE HAS NOT CHANGED | ||
| Unit Photos | Image: D2RF Digital Dynamic Remote System | Image: D2RS & D2RS9090 Digital Dynamic Remote System |
Comnarison Tahle
5
| | D2RF Digital Dynamic Remote System
K102529 | D2RS & D2RS9090 Digital Dynamic Remote
System |
|--------------------|-----------------------------------------------|--------------------------------------------------|
| Control
Console | |
Updated Look |
| | D2RF Digital Dynamic Remote
System K102529 | D2RS & D2RS9090 Digital Dynamic Remote
System |
|-----------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Canon CXDI-50RF panel
(The panel itself was cleared in 2009:
K092439) | New Panel: Canon CXDI-RF Wireless B1
Note: The Canon CXDI-50RF panel (cleared in
our original submission K102529) remains
available |
| Dimension | $492.8 \times 503.1$ mm | 480 x 460 mm |
| Useful Area | 35 x 43 cm | 42 x 43 cm |
| Photo | Image: Canon CXDI-50RF panel | Image: Canon CXDI-RF Wireless B1 panel |
| Scintillator | Csl | Csl |
| Pixel pitch | 160 μm | 160 μm |
| Spatial resolution | 3.1 lp/mm | 3.1 lp/mm |
| Matrix | $2208 \times 2688$ pixels | $2592 \times 2656$ pixels |
| AD conversion | 14 bits | 16 bits |
| DQE | 59% (0.5 lp/mm) | 60% (0.5 lp/mm) |
| MTF | 30% (2 lp/mm) | 38% (2 lp/mm) |
| | D2RF Digital Dynamic Remote
System K102529 | D2RS & D2RS9090 Digital Dynamic Remote
System |
| Fps Max | 30 fps | 30 fps |
| Interface | Ethernet | Ethernet/Wireless WiFi |
| DICOM 3 | YES | YES |
| Operating temperature | 15-40°C | 15-40°C |
6
-
- Bench/Performance Testing Data: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.) Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. For the new digital x-ray panel we provided testing according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Druq Administration Staff.
The X-Ray Units and digital panels have been tested to be in compliance with the following International Standards:
- Bench/Performance Testing Data: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Software was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (for a moderate level of concern.) Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. For the new digital x-ray panel we provided testing according to the FDA guidance document: Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Druq Administration Staff.
IEC 60601-12005 + CORR. 1 (2006) + CORR. 2 (2007), AMD1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-3:2008, AMD1:2013 for use in conjunction with IEC 60601-1:2005, AMD1:2012 Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
IEC 60601-1-2:2014 (Edition 4.0) General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - requirements and tests
IEC 60601-1-3:2008+A1:2013 (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
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 60601-2-28:2010 (Edition 2.0) Medical electrical equipment – Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-54:2009+A1:2015 (Edition 1.1) Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
IEC 62304:2006 + A1:2016 (Edition 1.1) . Medical device software life-cycle processes The unit complies with the US Performance Standard for radiographic equipment.
7
-
- Clinical Evaluation. As required by the FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices Guidance for Industry and Food and Drug Administration Staff A board certified radiologist reviewed both static and moving images and found them to be of excellent diagnostic quality.
-
- Conclusion: Based on our comparison of technological characteristics and our bench and clinical results, our conclusion is that the modified and updated system is as safe and effective as our predicate device and is therefore substantially equivalent.