(30 days)
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The GC70 digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
The GC70 digital X-ray imaging system consists of HVG (High Voltage Generator), ceiling suspension, X-ray tube, collimator, detector, wall stand, patient table, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, foot switch, barcode scanner, auto-stitching stand, weight distribution cap and workstation for S-station including Image Post-processing Engine (IPE).
The GC70 digital X-ray imaging system was previously cleared under K180543, and some hardware options and three software features are added to the predicate device GC70. The changes are as follows:
- Two High Voltage Generators
- . Two detectors
- . Slim wall stand
- . Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.
The Samsung GC70 Digital X-ray Imaging System, under K182647, is intended for generating radiographic images of human anatomy. This submission is a special 510(k) for changes to a previously cleared GC70 device (K180543), adding hardware options and three software features (S-Enhance, PEM, and Remote View) identical or similar to those cleared in predicate device GC85A (K181629).
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document for the new features. The submission relies on the assertion that the new hardware and software features are identical or similar to previously cleared predicates and have undergone verification and validation testing to meet requirement specifications, functioning as safely and effectively.
| Feature/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| General Safety and Effectiveness | Device should be as safe and effective as legally marketed predicate devices. | Non-clinical data demonstrates the proposed device is as safe, as effective, and performs as well as the legally marketed devices. |
| Electrical, Mechanical, Environmental Safety | Compliance with ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30, 21CFR1020.31. | All test results satisfied the standards. |
| EMC | Compliance with IEC 60601-1-2. | EMC testing was conducted in accordance with IEC 60601-1-2, and results were satisfying. |
| Wireless Functionality | Satisfy guidance for Radio frequency Wireless Technology in Medical Devices. | Wireless function was tested and verified followed by guidance "Radio frequency Wireless Technology in Medical Devices". |
| S-Enhance (Software) | Improve clarity of foreign bodies (tube, line) and stones in chest, abdomen, L-spine images. Create companion image without additional settings or x-ray exposure. | Verification and validation for software features (including S-Enhance) conducted in accordance with internal design change procedure. Requirement specifications were met. No difference in non-clinical testing data (MTF, DQE) from predicate. (Implicitly, the feature performs as intended, similar to how it performs on GC85A). |
| PEM (Software) | Subdivide patient size and exposure conditions for pediatric patients based on weight and protocols. Optimized for pediatric patients. | Verification and validation for software features (including PEM) conducted in accordance with internal design change procedure. Requirement specifications were met. No difference in non-clinical testing data (MTF, DQE) from predicate. (Implicitly, the feature performs as intended, similar to how it performs on GC85A). |
| Remote View (Software) | Provide images on another PC. | Verification and validation for software features (including Remote View) conducted in accordance with internal design change procedure. Requirement specifications were met. No difference in non-clinical testing data (MTF, DQE) from predicate. (Implicitly, the feature performs as intended, similar to how it performs on GC85A). |
| Non-clinical Imaging Performance (MTF, DQE) | Conformance to FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices" and IEC 62220-1. | Non-clinical testing data (MTF and DQE measurements) shows no difference from the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of image data for evaluating the clinical performance of the software features. The verification and validation of the software features were conducted "in accordance with internal design change procedure." The non-clinical testing data, including MTF and DQE measurements, were provided in conformance to FDA guidance for solid-state X-ray imaging devices. However, no specific sample size of images or patients is reported, and there is no information on the country of origin or whether data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The submission focuses on technical equivalence and verification/validation against internal specifications, rather than clinical performance studies requiring expert-adjudicated ground truth.
4. Adjudication method for the test set
This information is not provided. Given the nature of the submission (special 510(k) for hardware/software additions to an already cleared device, asserting equivalence), a formal adjudication process for a clinical test set is not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned or provided. The document explicitly states: "The application of these hardware options and software features, cleared with K181629, to the proposed device GC70 do not require clinical data." This indicates that no studies involving human readers or AI assistance were deemed necessary for this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study is described in the provided text. The software features (S-Enhance, PEM, Remote View) are described as tools or enhancements to the imaging system, rather than standalone diagnostic algorithms requiring independent performance metrics like sensitivity or specificity. Their verification and validation were conducted against "internal design change procedure" and "requirement specifications."
7. The type of ground truth used
The document does not detail the type of ground truth used as it does not report clinical efficacy studies. The "ground truth" for the non-clinical tests (MTF, DQE) would be based on physical measurements and established phantom standards (e.g., IEC 62220-1). For the software features, the "ground truth" was likely defined by internal "requirement specifications" within Samsung's design change procedures, focusing on functional correctness and qualitative improvements as described (e.g., "improve clarity," "subdivided patient size").
8. The sample size for the training set
This information is not provided. Since the software features are described as "optional software to improve clarity" or "subdivided patient size and exposure conditions" and are stated to be "identical or similar" to features in a predicate device, it's possible they involve image processing or rule-based systems rather than deep learning models that require large training sets. Even if machine learning was used, the training data details are not disclosed.
9. How the ground truth for the training set was established
This information is not provided. Similar to the training set sample size, the methodology for establishing ground truth for any potential training data is not detailed.
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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 & 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.
Samsung Electronics Co., Ltd. Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si. 16677 KR
Re: K182647
Trade/Device Name: GC70 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 21, 2018 Received: September 24, 2018
Dear Jaesang Noh:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
October 24, 2018
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Image /page/1/Picture/5 description: The image shows the name Michael D. O'hara -S in large font on the left side of the image. On the right side of the image is a digital signature with the name Michael D. O'hara -S. The signature includes the date 2018.10.24 07:38:20-04'00'.
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name GC70
Indications for Use (Describe)
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
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 Druq 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."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Premarket Notification - Special
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: September 21, 2018
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea
3. Primary Contact Person
- Name: JAESANG NOH & CHUNSIN KIM A.
- Title: Regulatory Affairs, Senior Professional B.
- C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437
- D. FAX Number: +82-31-200-6401
- E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com ப்
4. Secondary Contact Person
- A. Name: Genci Omari
- B. Title: Manager, Regulatory Affairs
- C. Phone Number: 978-564-8602
- D. FAX Number: 978-560-0602
- E-Mail: gomari@samsungneurologica.com ய்
5. Proposed Device
- A. Trade Name: GC70
- B. Device Name: GC70
- C. Common Name: Digital Diagnostic X-ray System
- D. Regulation Name: Stationary X-ray system
- E. Product Code: KPR
- Regulation: 21 CFR 892.1680 ட்
6. Predicate Devices
| Predicate Device #1 | Predicate Device #2(Primary Predicate) | |
|---|---|---|
| Device Name | GC85A | GC70 |
| Classification Name | Stationary X-raySystem | Stationary X-raySystem |
| Product Code | KPR | KPR |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 510(K)# | K181629 | K180543 |
| 510(K) Decision Date | July 20, 2018 | May 24, 2018 |
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Image /page/4/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is placed inside a blue, oval-shaped background.
510(k) Premarket Notification - Special
7. Device Description
The GC70 digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
The GC70 digital X-ray imaging system consists of HVG (High Voltage Generator), ceiling suspension, X-ray tube, collimator, detector, wall stand, patient table, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, foot switch, barcode scanner, auto-stitching stand, weight distribution cap and workstation for S-station including Image Post-processing Engine (IPE).
The GC70 digital X-ray imaging system was previously cleared under K180543, and some hardware options and three software features are added to the predicate device GC70. The changes are as follows:
- Two High Voltage Generators
- . Two detectors
- . Slim wall stand
- . Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.
8. Intended Use
The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
-
- Summary of Technological characteristic of the proposed device compared with
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510(k) Premarket Notification - Special
the predicate devices
The proposed device GC70 does not alter the intended use or the fundamental scientific technology and remains within the same classification for the same intended use as the predicate devices #1 and 2 because the proposed device GC70 uses the same X-ray generators, the same detectors, the similar wall stand, the same software features called as S-Enhance, PEM and Remote View of the predicate device GC85A, which were cleared with K181629, as a selective option of X-ray configuration. Verification and validation testing for these changes were successfully conducted in accordance with Samsung Design Change Process.
The following tables compare the main technological characteristics of the proposed device with the predicate devices to substantiate equivalence.
A. Comparing with Predicate Devices
The components and software features added to the proposed device are identical or similar to the predicate devices, which do not show significant difference in safety and effectiveness.
| Specification | Predicate Device #1 | Predicate Device#2 (PrimaryPredicate) | Proposed Device | Discussion |
|---|---|---|---|---|
| Device Name | GC85A | GC70 | GC70 | |
| Manufacturer | SAMSUNGELECTRONICS Co.,Ltd. | SAMSUNGELECTRONICSCo., Ltd. | SAMSUNGELECTRONICSCo., Ltd. | |
| 510(k) Number | K181629 | K180543 | None | |
| Appearances | Image: GC85A | Image: GC70 | Image: GC70 | Same asPD#2 |
| Intended Use | The GC85A digitalX-ray imagingsystem is intendedfor use in generatingradiographic imagesof human anatomyby a qualified/traineddoctor or technician.This device is notintended formammographicapplications. | The GC70 DigitalX-ray ImagingSystem isintended for usein generatingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications. | The GC70 DigitalX-ray ImagingSystem isintended for usein generatingradiographicimages of humananatomy by aqualified/traineddoctor ortechnician. Thisdevice is notintended formammographicapplications | Same asPD#2 |
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510(k) Premarket Notification - Special
| Manufacturer Contents | GC85A(K181629) | GC70(K180543) | GC70 | Discussion | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (1)High | Voltage Generator | |||||||||||
| Model Number | GXR-82 | GXR-52 | Z R 75 P N 80 | Z R 75 P N 50 | GXR-82 | GXR-52 | GXR-82 | GXR-52 | Z R 75 P N 80 | Z R 75 P N 50 | ||
| Max. Power | 82kW | 52kW | 80kW | 50kW | 82kW | 52kW | 82kW | 52kW | 80kW | 50kW | Same asPD#1&2 | |
| OutputRANGE | Tube Voltage | 40-15OkV | v40-15OkV | 40-15OkV | 40-15OkV | 40-150kV | v40-150kV | 40-15OkV | v40-15OkV | 40-15OkV | 40-15OkV | Same asPD#1&2 |
| Tube Current | 10-1000mA | 10-6400mA | 10-1000mA | 10-6300mA | 10-1000mA | 10-640mA | 10-1000mA | 10-6400mA | 10-1000mA | 10-6300mA | Same asPD#1&2 | |
| ExposureTime | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | 1msec-10sec | Same asPD#1&2 | |
| AEC(Automatic ExposureControl) | Yes | Yes | Yes | Same | ||||||||
| APR (AnatomicallyProgrammedRadiography) | Yes | Yes | Yes | Same |
| Manufacturer Contents | GC85A(K181629) | GC70(K180543) | GC70 | Discussion | |
|---|---|---|---|---|---|
| (2) Wall Stand | |||||
| Model number | SDR-OGST80U | SDR-OGST73A/B | SDR-OGST73A/B | SDR-OGST73A/B is thesame asPD#1&2and SDR-OGST73Cis new | |
| VerticalMovement | Mechanism | Motorized | Motorized | Motorized | Same |
| Range(mm) | 280~1850 | 412~1838 | 412~1838 | Same asPD#1&2 | |
| Detector/tube servocoupling | Yes | Yes | Yes | Same |
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510(k) Premarket Notification - Special
| Manufacturer Contents | GC85A(K181629) | GC70(K180543) | GC70 | Discussion | ||
|---|---|---|---|---|---|---|
| Detector | Tilting | Motorized | Motorized | Motorized | None | SDR-OGST73A/B is the same asPD#1&2 and SDR-OGST73Cis new |
| 20~+90 | 20~+90 | 30~+90 | None | SDR-OGST73A/B is the same asPD#1&2 and SDR-OGST73Cis new | ||
| AEC | Conventional | Conventional | Conventional | Same | ||
| Grid | Lines/cm | 85/92 | 85/92 | 85/92 | Same | |
| Grid mechanism | Stationary | Stationary | Stationary | Same | ||
| Removability | Removable | Removable | Removable | Same | ||
| Detector SupportMounting | Floor | Floor | Floor | Same | ||
| Patient Support Device | Patient handgrips,lateral support bar | Patient handgrips,lateral support bar | Patient handgrips,lateral support bar | Same | ||
| ManufacturerContents | GC85A(K181629) | GC70(K180543) | GC70 | Discussion | ||
| (3) Detector | ||||||
| Name(Model Number) | S4335-WS4343-WS3025-WS4335-AWS4343-AW | S4335-WS4343-WS3025-W | S4335-WS4343-WS3025-WS4335-AWS4343-AW | Same asPD#1 | ||
| S4335-AWS4343-AW | S4335-W | S4343-W | ||||
| Detector Type | CslIndirect | CslIndirect | CslIndirect | Same | ||
| Detector Area | 14"X17"(345m | 17"X17"(425m | 14"X17"(345m17"X17"(425m | Same |
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510(k) Premarket Notification - Special
| ManufacturerContents | GC85A(K181629) | GC85A(K181629) | GC70(K180543) | GC70(K180543) | GC70 | GC70 | Discussion |
|---|---|---|---|---|---|---|---|
| mX425mm) | mX425mm) | mX425mm) | mX425mm) | mX425mm) | mX425mm) | ||
| Number of pixels | 2466X3040 | 3036X3040 | 2466X3040 | 3036X3040 | 2466X3040 | 3036X3040 | Same |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same |
| High ContrastLimiting Resolution(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same |
| Communication | Wired /Wirelesss | Wired /Wirelesss | Wired /Wirelesss | Wired /Wirelesss | Wired /Wirelesss | Wired /Wirelesss | Same |
| Dust/Water-resistance | IP54 | IPx1 | IP54 | Same asPD#1 | |||
| Max.load capacity | 400 kg for uniformload, | 150 kg for uniformload, | 400 kg for uniformload, | ||||
| 200 kg for local | 100 kg for local | 200 kg for local | Same asPD#1 | ||||
| load (40 | mm indiameter disk atthe center) | load (40 | mm indiameter disk atthe center) | load (40 | mm indiameter disk atthe center) | PD#1 |
| Manufacturer Contents | GC85A(K181629) | GC70(K180543) | GC70 | Discussion |
|---|---|---|---|---|
| (4) Software Features | ||||
| Feature Names | SimGrid | SimGrid | SimGrid | Same |
| S-Guide | S-Guide | S-Guide | Same | |
| S-Enhance | - | S-Enhance | Same asPD#1 | |
| PEM | - | PEM | Same asPD#1 | |
| S-DAP | S-DAP | S-DAP | Same | |
| S-Align | S-Align | S-Align | Same | |
| S-Share | S-Share | S-Share | Same | |
| BSI | BSI | BSI | Same | |
| Remote View | - | Remote View | Same asPD#1 |
B. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
C. Non-clinical data
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510(k) Premarket Notification - Special
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
D. Clinical data
The application of these hardware options and software features, cleared with K181629, to the proposed device GC70 do not require clinical data.
E. Conclusions
The non-clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.
§ 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.