(24 days)
No
The summary describes a standard X-ray RF system with tomosynthesis capabilities and mentions image processing, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The focus is on hardware and basic image manipulation/storage.
No.
The device is clearly stated as being for "fluoroscopy/radiography diagnosis" and "NOT intended to be used for interventional procedure", indicating a diagnostic purpose rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital." This directly indicates its diagnostic purpose.
No
The device description clearly states it is a universal X-ray RF system with hardware components like a floor-mounted table, digital radiography system, X-ray High Voltage Generator, Collimator, X-ray Tube, and a digital x-ray receptor panel. While it mentions a "Tomosynthesis option" enabled by additional software, the core device is a hardware system.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the equipment is for "fluoroscopy/radiography diagnosis in hospital." This involves imaging the internal structures of the body using X-rays, which is a diagnostic imaging technique performed on the patient, not on a sample taken from the patient.
- Device Description: The description details an X-ray RF system, including components like an X-ray tube, generator, and digital receptor panel. These are all components of an imaging system, not a system designed to analyze biological samples.
- Lack of IVD Characteristics: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological samples.
The device is a medical imaging device used for diagnostic purposes, but it falls under the category of diagnostic imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
JAA
Device Description
The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4. The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube. The purpose of this submission is to introduce an additional compatible digital x-ray receptor panel. This panel is manufactured by Canon. The panel was cleared by FDA for fluoroscopic use in K171194.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy including chest or extremities
Indicated Patient Age Range
total patient population
Intended User / Care Setting
qualified personnel, such as radiography technicians or those with equivalent qualifications. hospital.
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 additional digital receptor panel was subjected to non-clinical testing by its manufacturer, Canon. Our own testing consisted of integration testing, taking and evaluation of test images (both moving and still) and risk analysis oriented to the risks of making the panel manufacturer change.
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 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.
Shimadzu Corporation % Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114
March 15, 2019
Re: K190373
Trade/Device Name: SONIALVISION G4 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: January 27, 2019 Received: February 19, 2019
Dear Mr. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SONIALVISION G4
Indications for Use (Describe)
The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital.
The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications.
The equipment is used for total patient population.
The equipment is NOT intended to be used for Mammography screening.
The equipment is NOT intended to be used for interventional procedure.
The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations.
Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server.
The Tomosynthesis option for the SONIAL VISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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: 510(k) Number K190373 Shimadzu Corporation 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto, 604-8511, Japan Registration Number: 8030233 Phone : +81-75-823-1305 Fax : +81-75-823-1377 Date Prepared: March 4, 2019 Contact: Toshio Kadowaki; Phone: +81-75-823-1920 E-mail: kadowaki@shimadzu.co.jp
-
- Identification of the Device: Trade/Device Names: SONIALVISION G4 Regulation Number: 21CFR892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Common/Usual Name: fluoroscopic x-ray system
-
- Equivalent legally marketed device: K142341 Trade/Device Name: SONIALVISION G4 Manufacturer: Shimadzu. Regulation Number: 21CFR892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Common/Usual Name: fluoroscopic x-ray system
-
- Reference device (new digital panel employed: K171194) Trade/Device Name: AS-10, CXDI-401RF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, MQB
-
- Indications for Use (intended use): The equipment is intended to be used for the fluoroscopy/radiography diagnosis in hospital. The equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. The equipment is used for total patient population. The equipment is NOT intended to be used for Mammography screening. The equipment is NOT intended to be used for interventional procedure. The equipment is used for radiographic, fluoroscopic, angiographic and pediatric examinations. Stored images in the equipment can be used for re-monitoring, image processing, storing to optical media (CD/DVD), and sending to DICOM server. The Tomosynthesis option for the SONIALVISION G4 is intended to generate tomographic images of human anatomy including chest or extremities. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is not intended for mammographic applications.
-
- Description of the Device: The Shimadzu SONIALVISION G4 is a universal X-ray RF system offering radiographic, fluoroscopic, angiographic and tomosynthesis techniques. Tomosynthesis technique is enabled by additional software option to the digital radiography system of the SONIALVISION G4.
4
The Shimadzu SONIALVISION G4 is floor mounted table, and the system can be configured with Digital Radiography System, X-ray High Voltage Generator, Collimator and X-ray Tube. The purpose of this submission is to introduce an additional compatible digital x-ray receptor panel. This panel is manufactured by Canon. The panel was cleared by FDA for fluoroscopic use in K171194.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench testing indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.
| K142341, SONIALVISION G4 | MODIFIED SONIALVISION G4 | |
|---|---|---|
| Indications for | ||
| Use: | The equipment is intended to be used for the | |
| fluoroscopy/radiography diagnosis in hospital. The | ||
| equipment must only be operated by qualified | ||
| personnel, such as radiography technicians or those | ||
| with equivalent qualifications. The equipment is used | ||
| for total patient population. The equipment is NOT | ||
| intended to be used for Mammography screening. The | ||
| equipment is NOT intended to be used for | ||
| interventional procedure. The equipment is used for | ||
| radiographic, fluoroscopic, angiographic and pediatric | ||
| examinations. Stored images in the equipment can be | ||
| used for re-monitoring, image processing, storing to | ||
| optical media (CD/DVD), and sending to DICOM server. | ||
| The Tomosynthesis option for the SONIALVISION G4 is | ||
| intended to generate tomographic images of human | ||
| anatomy including chest or extremities. Tomosynthesis | ||
| technique is used to produce a specific cross-sectional | ||
| plane of the body by reconstruction of tomographic | ||
| acquisition. The device is not intended for | ||
| mammographic applications | ||
| Note: All technical characteristics for the predicate and the modified system are IDENTICAL except for the digital | ||
| receptor panels, which are compared below. | The equipment is intended to be used for the | |
| fluoroscopy/radiography diagnosis in hospital. The | ||
| equipment must only be operated by qualified | ||
| personnel, such as radiography technicians or those | ||
| with equivalent qualifications. The equipment is used | ||
| for total patient population. The equipment is NOT | ||
| intended to be used for Mammography screening. The | ||
| equipment is NOT intended to be used for | ||
| interventional procedure. The equipment is used for | ||
| radiographic, fluoroscopic, angiographic and pediatric | ||
| examinations. Stored images in the equipment can be | ||
| used for re-monitoring, image processing, storing to | ||
| optical media (CD/DVD), and sending to DICOM server. | ||
| The Tomosynthesis option for the SONIALVISION G4 is | ||
| intended to generate tomographic images of human | ||
| anatomy including chest or extremities. Tomosynthesis | ||
| technique is used to produce a specific cross-sectional | ||
| plane of the body by reconstruction of tomographic | ||
| acquisition. The device is not intended for | ||
| mammographic applications EXACTLY THE SAME | ||
| Manufacturer | Varian Medical Systems | Varian Medical Systems OR |
| Canon Medical Equipment Group | ||
| Model | PaxScan™ 4343CB, our model number | |
| SDF-1717AF | PaxScan™ 4343CB, our model number | |
| SDF-1717AF | ||
| OR: | ||
| Canon AS-10, CXDI-401RF (K171194) | ||
| our model number SFD-1717BF | ||
| Size | 43 x 43 CM | SAME |
| Pixel Size | 139μm | 160 μm |
| Number of Pixels | 3072 x 3072 | 2,688 x 2,688 |
| Acquisition | Up to 3 fps (1x1) | |
| Up to 15 fps (1x1 or 2x2) | Up to 3 fps (1x1) | |
| Up to 15 fps (1x1) | ||
| K142341, SONIALVISION G4 | MODIFIED SONIALVISION G4 | |
| Spatial Resolution | ||
| [MTF@2cycle/mm, | ||
| RQA5] | 0.28 | 0.28 Same performance |
| A/D Conversion | 16 Bit | 16 Bit |
| Photo of Panel (the | ||
| modified part) | Added Compatible Panel |
Up to 30 fps (2x2)
0.75 Slightly better
Equivalent performance
-
- Substantial Equivalence Chart: Below.
Up to 30 fps (2x2)
- Substantial Equivalence Chart: Below.
0.70
Modes (Binning)
DQE @ 1 µGy in 0
lp/mm, RQA5
5
-
- Summary of non-clinical testing: The additional digital receptor panel was subjected to non-clinical testing by its manufacturer, Canon. See K171194 at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/[K171194](https://510k.innolitics.com/search/K171194).pdf Our own testing consisted of integration testing, taking and evaluation of test images (both moving and still) and risk analysis oriented to the risks of making the panel manufacturer change. The Users Manual was updated, and supplements were added for Pediatric Imaging (FDA Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications ) and for Cybersecurity (FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.)
-
- Summary of clinical testing: Not applicable. Clinical testing was not deemed to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
-
- Conclusion: After analyzing bench tests, it is the conclusion of Shimadzu Corporation that the MODIFIED SONIALVISION G4 is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.