(90 days)
No
The document describes a standard digital X-ray imaging system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is used for generating radiographic images for diagnosis, not for treating conditions.
Yes
The device generates radiographic images for use in diagnosing conditions related to the skeletal, respiratory, and urinary systems, which indicates a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including X-ray control, high-voltage generator, X-ray tube support, irradiation equipment, detectors, and a patient photography stand, in addition to software.
Based on the provided text, the GR10X Digital X-ray Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The GR10X system generates radiographic images of human anatomy by passing X-rays through the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy." This is a diagnostic imaging function, not an in vitro diagnostic function.
- Device Description: The description details components related to X-ray generation, detection, and image processing, all of which are characteristic of an imaging system, not an IVD.
Therefore, the GR10X Digital X-ray Imaging System falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
This device consists of X-ray control, high-voltage generator, X-ray tube support, irradiation equipment, detectors, patient photography stand, digital imaging device, viewer SW, etc. The detectors and the viewer SW are cleared under the following 510ks.
- VIVIX-S VW(K200418) . Model Names: FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively.
A high frequency inverter (Inverter) X-sensor voltage device designed to generate X-rays by combination of tube voltage, tube current, irradiation time, etc. so that it can be filmed at various angles for diagnosis of the patient's skeletal, respiratory, and urinary systems. The digital imaging system is used to obtain the images taken by the X-ray unit as radiation from the X-ray unit passes through the human body and is transmitted by the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software, VXvue, acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors.
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
hospitals, clinics, and medical practices.
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)
A comparison test was conducted between the subject devices and the predicate device (K081722) on the items such as DQE, MTF and spatial resolution.
A single-blinded concurrence study was conducted, and the study confirmed that the GR10X Digital X-ray Imaging System provides images of equivalent diagnostic capability to the predicate devices, the Yiso and its results demonstrate substantial equivalence.
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
§ 892.1680 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.
0
April 19, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services-USA on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue as well.
XERA Medical Systems & Technology Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 IRVINE CA 92612
Re: K220149
Trade/Device Name: GR10X-40K GR10X-50K Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: January 17, 2022 Received: January 19, 2022
Dear Priscilla Chung:
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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K220149
Device Name GR10X-40K GR10X-50K
Indications for Use (Describe)
The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic 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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3
510(k) Summary
[As required by 21 CFR 807.92]
This 510(k) summary information is prepared in accordance with 21 CFR807.92.
1. Date Prepared [21 CFR 807.92(a) (1)]
4/12/2022
2. Submitter's Information [21 CFR 807.92(a) (1)]
| Name of Sponsor: | Xera Medical Systems and Technology Ltd. |
|---|---|
| Address: | Gulden Sk. 13/2 Kavaklidere, Ankara, Turkey |
| Contact Name: | Oh, Kevin / Regulatory Affairs Associate |
| Registration Number: | 3006013411 |
| Name of Manufacturer: | Same as Sponsor |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Trade Name: | OCTAVE |
|---|---|
| Model Name: | GR10X-40K, 50K |
| Common Name: | General Radiography X-ray System |
| Classification Name: | System, X-Ray, Stationary |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR 892.1680 |
| Product Code: | KPR |
| Device Class: | 2 |
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
510(k) Number: K081722 Product Code: KPR Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC. Trade Name: Ysio Decision Date: 03/15/2018 Type: Traditional
5. Description of the Device [21 CFR 807.92(a) (4)]
This device consists of X-ray control, high-voltage generator, X-ray tube support, irradiation equipment, detectors, patient photography stand, digital imaging device, viewer SW, etc. The detectors and the viewer SW are cleared under the following 510ks.
4
- VIVIX-S VW(K200418) . Model Names: FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively.
A high frequency inverter (Inverter) X-sensor voltage device designed to generate X-rays by combination of tube voltage, tube current, irradiation time, etc. so that it can be filmed at various angles for diagnosis of the patient's skeletal, respiratory, and urinary systems. The digital imaging system is used to obtain the images taken by the X-ray unit as radiation from the X-ray unit passes through the human body and is transmitted by the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software, VXvue, acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors.
6. Indications for Use [21 CFR 807.92(a)(5)]
The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
Comparisons with the predicate, the system shows the technological characteristics of the proposed GR10X-40K, 50K device to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K081722), the GR10X-40K has the subsequently equivalent:
- Intended Use
- Technological characteristics
- · Operating principle
- · Design features
- Communication Method
There is no significant difference between the GR10X Digital X-ray Imaging System and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
5
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Feature | Ysio | GR10X-40K | GR10X-50K |
| Indications for Use | The Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen ,and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio system is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography(CR) cassettes. | The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications. |
Table 1: Comparison of Subject Device GR10X-40K, 50K to the Predicate
Table 2: Comparison of Subject Device GR10X-40K, 50K to the Predicate
| Predicate Device | Subject Device | |||
|---|---|---|---|---|
| Feature | Ysio | GR10X-40K | GR10X-50K | Comparison |
| Results | ||||
| Technical Comparison | ||||
| X-ray | ||||
| Generator | Polydoros | |||
| 65/80 kW | DMG-40KAX A | DMG-50KAX B | ||
| X-ray tube | OPTITOP | |||
| 150/40/80/HC-100 | E7239X | E7252X | ||
| Collimator | Collimator N | M38 | Substantially | |
| Equivalent | ||||
| X-ray techniques | Radiography | Radiography | ||
| Organ programs | X-ray parameters | |||
| Imaging processing | ||||
| parameters | X-ray parameters | |||
| Imaging processing | ||||
| parameters | ||||
| Testing |
6
| IEC Compliance | IEC 4th edition for
EMC testing | IEC 4th edition for
EMC testing | Testing according to
current IEC test
scope |
|----------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------|
| Digital Imaging | | | |
| SSXI for Rad imaging | Trixell Pixium
MAX wi-D =
3543EZh
MAX mini = 2430EZ
MAX Static =
4343RC | VIVIX-S 4343VW,
VIVIX-S 3643VW,
VIVIX-S 2530VW,
VIVIX-S 1717V | Substantially
Equivalent |
Table 3: Comparison of VIVIX-S VW Series and VIVIX-S 1717V to the predicate Trixell Pixium 4343RCE to the predicate Trixell Pixium 4343RCE
| Technical
Specifications | Trixell Pixium 4343RCE
detector | VIVIX-S VW Series, VIVIX-
S 1717V
(Subject) | Comparison
Results |
|-----------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Dimensions | 423.3mm x 425.4 mm | VIVIX-S 4343VW: 460 mm x 460 mm
VIVIX-S 3643VW: 384mm × 460mm
VIVIX-S 2530VW: 287mm x 350mm
VIVIX-S 1717V: 460mm x 460mm | Substantially Equivalent |
| Resolution | 2860 x 2874 pixels | VIVIX-S 4343VW: 3072 x 3072 pixels
VIVIX-S 3643VW: 2560 x 3072 pixels
VIVIX-S 2530VW: 2048 x 2560 pixels
VIVIX-S 1717V: 3072 x 3072 pixels | Substantially Equivalent |
| Pixel size | 148 µm | VIVIX-S 4343VW: 140µm
VIVIX-S 3643VW: 140µm
VIVIX-S 2530VW: 124µm
VIVIX-S 1717V: 140µm | Substantially Equivalent |
| Semiconductor
Material | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Substantially Equivalent |
| Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI),
Gadolinium Oxide(Gadox) | Substantially Equivalent |
| Acquisition
depth | 16 bit | 16 bit | Substantially Equivalent |
7
| DQE (Detective Quantum Efficiency) | DQE @ 0.05 lp/mm (2 µGy), 67% | FXRD-4343VAW: | Substantially Equivalent |
|---|---|---|---|
| 47% | |||
| FXRD-4343VAW PLUS: | |||
| 62% | |||
| FXRD-3643VAW: | |||
| 45.5% | |||
| FXRD-3643VAW PLUS: | |||
| 61% | |||
| FXRD-2530VAW: | |||
| 49% | |||
| FXRD-2530VAW PLUS: | |||
| 61% | |||
| FXRD-1717NAW: | |||
| 50% | |||
| FXRD-1717NBW: | |||
| 27% | |||
| MTF (Modulations transfer function) | MTF @ 1 lp/mm, 62% | FXRD-4343VAW: | |
| 76% | |||
| FXRD-4343VAW PLUS: | |||
| 60% | |||
| FXRD-3643VAW: | |||
| 74% | |||
| FXRD-3643VAW PLUS: | |||
| 61% | |||
| FXRD-2530VAW: | |||
| 76% | |||
| FXRD-2530VAW PLUS: | |||
| 60% | |||
| FXRD-1717NAW: | |||
| 66% | |||
| FXRD-1717NBW: | Substantially Equivalent |
9. Summary of Non-Clinical Data
A comparison test was conducted between the subject devices and the predicate device (K081722) on the items such as DQE, MTF and spatial resolution.
These detectors comply with the following international and FDA-recognized consensus standards:
- 21CFR1020.30, Diagnostic X-ray Systems, and their major components
- 21CFR1020.31, Radiographic equipment
- IEC 60601-1 Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and Essential Performance.
- CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Equipment –Part 1 : General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada)
8
- ANSI/AAMI ES60601-1 (2005+ C1:09+A2:10) (Medical Electrical Equipment Part 1
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2 : General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
We also referenced the following FDA guidance:
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, Document issued on: May 11, 2005 Medical Devices, Document issued on: May 11, 2005
- Guidance for Industry and Food and Drug Administration Staff Pediatric Information for X-ray Imaging Device Premarket Notifications, November 2017
10. Summary of Clinical Data
A single-blinded concurrence study was conducted, and the study confirmed that the GR10X Digital X-ray Imaging System provides images of equivalent diagnostic capability to the predicate devices, the Yiso and its results demonstrate substantial equivalence.
11. Conclusion [21 CFR 807.92(b) (3)]
The GR10X Digital X-ray Imaging System is substantially equivalent to the currently marketed and predicate devices (K081722) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-1, IEC 60601-1-2, 3 and the clinical test. The results of these tests demonstrate that GR10X Digital X-ray Imaging System meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well the predicate devices.