(30 days)
No
The document describes standard image processing techniques and preset management, but does not mention AI or ML.
No
This device is an X-ray imaging system, which is used for diagnostic purposes (generating images of human anatomy) and not for treating or curing a disease or condition.
Yes
The "Intended Use / Indications for Use" states the device is "intended for use in generating radiographic images of human anatomy", and the "Device Description" states it is "designed for general radiography and used to capture images". The description also mentions that the images are saved in DICOM file, which is a standard for medical imaging, and sent to "PACS sever for reading images". This indicates its role in providing images for diagnostic purposes. Furthermore, the mentioning of "Samsung Digital Diagnostic X-ray System" in the description explicitly uses the term "Diagnostic".
No
The device description explicitly lists numerous hardware components (HVG, ceiling suspension, X-ray tube, detector, etc.) that are part of the system, indicating it is not software-only.
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 device is for "generating radiographic images of human anatomy." This involves imaging the internal structure of the body using X-rays.
- Device Description: The description details a system that transmits X-rays through a patient's body and captures the resulting image using a detector. This is the core function of an X-ray imaging system.
- Lack of Biological Sample Analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases or conditions. There is no mention of collecting or analyzing biological samples with this device.
- Imaging Modality: The input imaging modality is X-ray, which is a form of medical imaging, not a method for analyzing biological samples.
Therefore, the GC70 Digital X-ray Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
Product codes
KPR
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.
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
qualified/trained doctor or technician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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 & 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
1
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
2
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.
3
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-ray
System | Stationary X-ray
System |
| 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
5
Image /page/5/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The background is in the shape of an oval that is tilted slightly to the right.
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 (Primary
Predicate) | Proposed Device | Discussion |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Device Name | GC85A | GC70 | GC70 | |
| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | SAMSUNG
ELECTRONICS
Co., Ltd. | SAMSUNG
ELECTRONICS
Co., Ltd. | |
| 510(k) Number | K181629 | K180543 | None | |
| Appearances | Image: GC85A | Image: GC70 | Image: GC70 | Same as
PD#2 |
| Intended Use | The GC85A 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
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
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 | Same as
PD#2 |
6
Image /page/6/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval.
510(k) Premarket Notification - Special
| Manufacturer Contents | GC85A
(K181629) | GC70
(K180543) | GC70 | Discussion | | | | | | | | |
|-------------------------------------------------|--------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------|--------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------|
| (1)High | Voltage Generator | | | | | | | | | | | |
| Model Number | G
X
R-
82 | G
X
R-
52 | Z R 75 P N 80 | Z R 75 P N 50 | GXR-82 | GXR-52 | G
X
R-
82 | G
X
R-
52 | Z R 75 P N 80 | Z R 75 P N 50 | | |
| | Max. Power | 82
k
W | 52
k
W | 80
k
W | 50
k
W | 82kW | 52kW | 82
k
W | 52
k
W | 80
k
W | 50
k
W | Same as
PD#1&2 |
| Output
RANGE | Tube Voltage | 40
15
Ok
V | v4
0-
15
Ok
V | 40
15
Ok
V | 40
15
Ok
V | 40-
150kV | v40-
150kV | 40
15
Ok
V | v4
0-
15
Ok
V | 40
15
Ok
V | 40
15
Ok
V | Same as
PD#1&2 |
| | Tube Current | 10
10
00
m
A | 10
64
00
m
A | 10
10
00
m
A | 10
63
00
m
A | 10-
1000m
A | 10-
640mA | 10
10
00
m
A | 10
64
00
m
A | 10
10
00
m
A | 10
63
00
m
A | Same as
PD#1&2 |
| | Exposure
Time | 1
m
se
c-
10
se
c | 1
m
se
c-
10
se
c | 1
m
se
c-
10
se
c | 1
m
se
c-
10
se
c | 1msec-
10sec | 1msec-
10sec | 1
m
se
c-
10
se
c | 1
m
se
c-
10
se
c | 1
m
se
c-
10
se
c | 1
m
se
c-
10
se
c | Same as
PD#1&2 |
| AEC
(Automatic Exposure
Control) | | Yes | | | | Yes | | Yes | | | | Same |
| APR (Anatomically
Programmed
Radiography) | | Yes | | | | Yes | | Yes | | | | Same |
| Manufacturer Contents | | GC85A
(K181629) | GC70
(K180543) | GC70 | Discussion |
|---------------------------------|-----------|---------------------|-----------------------|-------------------|------------------------------------------------------------------------------------|
| (2) Wall Stand | | | | | |
| Model number | | SDR-
OGST
80U | SDR-
OGST
73A/B | SDR-
OGST73A/B | SDR-
OGST73A/
B is the
same as
PD#1&2
and SDR-
OGST73C
is new |
| Vertical
Movement | Mechanism | Motorized | Motorized | Motorized | Same |
| | Range(mm) | 28011
850 | 412
838 | 412~1838 | Same as
PD#1&2 |
| Detector/tube servo
coupling | | Yes | Yes | Yes | Same |
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Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.
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 as
PD#1&2 and SDR-OGST73C
is new |
| | | 20~+90 | 20~+90 | 30~+90 | None | SDR-OGST73A/
B is the same as
PD#1&2 and SDR-OGST73C
is 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 Support
Mounting | | Floor | Floor | Floor | Same | |
| Patient Support Device | | Patient handgrips,
lateral support bar | Patient handgrips,
lateral support bar | Patient handgrips,
lateral support bar | Same | |
| Manufacturer
Contents | GC85A
(K181629) | GC70
(K180543) | | GC70 | Discussion | |
| (3) Detector | | | | | | |
| Name
(Model Number) | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW | S4335-W
S4343-W
S3025-W | | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW | Same as
PD#1 | |
| | S4335-AW
S4343-AW | S4335-W | S4343-W | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| Detector Type | Csl
Indirect | Csl
Indirect | | Csl
Indirect | Same | |
| Detector Area | 14"X17
"(345m | 17"X17
"(425m | | 14"X17
"(345m
17"X17
"(425m | Same | |
8
Image /page/8/Picture/1 description: The image shows the Samsung logo. The logo is white text on a blue background. The text is in a bold, sans-serif font. The logo is simple and recognizable.
510(k) Premarket Notification - Special
| Manufacturer
Contents | GC85A
(K181629) | GC85A
(K181629) | GC70
(K180543) | GC70
(K180543) | GC70 | GC70 | Discussion |
|-------------------------------------------------|-----------------------------|------------------------------------------|-----------------------------|------------------------------------------|-----------------------------|------------------------------------------|-----------------|
| | mX425
mm) | mX425
mm) | mX425
mm) | mX425
mm) | mX425
mm) | mX425
mm) | |
| Number of pixels | 2466X
3040 | 3036X
3040 | 2466X
3040 | 3036X
3040 | 2466X
3040 | 3036X
3040 | Same |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same |
| High Contrast
Limiting Resolution
(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same |
| Communication | Wired /
Wireless
s | Wired /
Wireless
s | Wired /
Wireless
s | Wired /
Wireless
s | Wired /
Wireless
s | Wired /
Wireless
s | Same |
| Dust/Water-
resistance | IP54 | | IPx1 | | IP54 | | Same as
PD#1 |
| Max.load capacity | 400 kg for uniform
load, | | 150 kg for uniform
load, | | 400 kg for uniform
load, | | |
| | 200 kg for local | | 100 kg for local | | 200 kg for local | | Same as
PD#1 |
| | load (40 | mm in
diameter disk at
the center) | load (40 | mm in
diameter disk at
the center) | load (40 | mm in
diameter disk at
the 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 as
PD#1 |
| | PEM | - | PEM | Same as
PD#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 as
PD#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.