GC70

• K Number: K163115
• Device Name: GC70
• Manufacturer: SAMSUNG ELECTRONICS CO., LTD.
• Date Cleared: 2016-12-07 ( 30 days)
• Product Code: KPR
• Regulation Number: 892.1680

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.

Device Description

The GC70 digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

Predicate Devices

K160997

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard digital X-ray imaging processes and does not mention AI or ML capabilities. While image processing is mentioned, it's a common feature in digital imaging and not necessarily indicative of AI/ML.

Therapeutic

No
The device is an imaging system designed to generate radiographic images for diagnostic purposes, not to treat or cure any medical condition.

Diagnostic

Yes
This device is a diagnostic device as it is used to generate radiographic images for the purpose of reading and evaluating human anatomy. The images are sent to a PACS server and can be used for "reading images," which implies diagnostic interpretation.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like an X-ray generator, detector, and signal processing device, in addition to the operation software.

IVD (In Vitro Diagnostic)

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 is a diagnostic imaging device, not a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body).
• Device Description: The description details the process of capturing X-ray images of a patient's body and converting them into digital data for viewing and storage. This is consistent with an imaging system, not an IVD.
• Input Imaging Modality: The input modality is X-ray, which is a form of medical imaging, not a method used for in vitro diagnostics.

IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by imaging the body directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

KPR

Device Description

The GC70 digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

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)

• Study type: Phantom image evaluations
• Sample size: Not Specified
• AUC: Not Specified
• MRMC: Not Specified
• Standalone performance: Not Specified
• Key results: They were evaluated by a professional radiologist and found to be equivalent to the predicate device.

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.

K160997

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.

Not Found

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 7, 2016

SAMSUNG ELECTRONICS Co., Ltd. % Mr. Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA

Re: K163115

Trade/Device Name: GC70 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 31, 2016 Received: November 7, 2016

Dear Mr. Kim:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

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)

K163115

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.

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) 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 [e-mail]

"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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

3

Image /page/3/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue oval background. The oval is tilted slightly to the right.

510(k) Premarket Notification - Traditional

Section 5: 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92

• 1. Date: Oct 31, 2016

2. Submitter

• Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
• Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, B. Republic of Korea

3. Primary Contact Person

• A. Name: KIM, CHULSIN
• B. Title: Regulatory Affairs Manager
• Phone Number: [phone] ﻥ
• FAX Number: [phone] D. E-Mail: [e-mail]

4. Secondary Contact Person

• A. Name: Ninad Gujar
• B. Title: Director of Regulatory Affairs
• C. Phone Number: 978-564-8503
• FAX Number: 978-750-6677 D. E-Mail: [e-mail]

5. Proposed Device

• A. Trade Name: GC70
• B. Device Name: GC70
• C. Common Name: Digital Diagnostic X-ray System
• Classification Name: Stationary x-ray system D.
• E. Product Code: KPR
• F. Regulation: 21 CFR 892.1680

6. Predicate Devices

• A. Trade Name: GC85A
• B. Device Name: GC85A
• Common Name: Digital Diagnostic X-ray System ﻥ
• D. Classification Name: Stationary x-ray system
• Product Code: KPR ய்
• ட் Regulation: 21 CFR 892.1680
• G. 510(k): K160997

7. Device Description

The GC70 digital X-ray imaging system is used to capture images by transmitting X-ray

4

Image /page/4/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 - Traditional

to a patient's body. The X-ray 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 device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

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.

9. Summary of Technological characteristic of the proposed device compared with the predicate devices

The proposed device, GC70, has same detectors and image processing as the predicate device so it does not have significant changes in imaging performance in comparison to the predicate device, and has few configuration options more as HVG(High Voltage Generator), Wall Stand and Patient Table are added.

Specification	Predicate Device	Proposed Device	Discussion
Device Name	GC85A	GC70
Manufacturer	SAMSUNG ELECTRONICS
Co., Ltd.	SAMSUNG ELECTRONICS
Co., Ltd.	Same
510(k) Number	K160997	None
Appearances	Image: GC85A X-ray machine	Image: GC70 X-ray machine	Difference(1)
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.	Same
Manufacturer Contents	GC85A
(K160997)	GC70	Discussion
(1)High Voltage Generator

A. Comparing with Predicate Device

5

Image /page/5/Picture/1 description: The image shows the Samsung logo. The logo is a blue oval with the word "SAMSUNG" in white letters. The letters are bold and sans-serif. The logo is simple and recognizable.

510(k) Premarket Notification - Traditional

| Manufacturer Contents | GC85A
(K160997) | GC70 | Discussion | |
|-----------------------|--------------------|-------------|--------------------------|--------------------------|
| Max. Power | 82kW | 52kW | Same &
Differences(2) | |
| Output
RANGE | Tube Voltage | 40-150kV | 40-150kV | Same |
| | Tube Current | 10-1000mA | 10-640mA | Same &
Differences(3) |
| | Exposure Time | 1msec-10sec | 1msec-10sec | Same |

Manufacturer Contents			GC85A (K160997)	GC70	Discussion
(3) Wall Stand
Vertical
Movement	Mechanis
m	Motorized	Motorized	Same
	Range(m
m)	280~1850	412~1838	Differences(4)
Detec
tor	Tilting	Motorized	Motorized	Motorized	Same
		-20~+90	-20~+90	-30~+90	Differences(5)

| Manufacturer Contents | GC85A
(K160997) | GC70 | Discussion | | |
|-------------------------------------|--------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|------------------------------------------------------|
| (4)Patient Table | | | | | |
| Table
Top | Size(mm) | 2410 X 812 | 2410 X 812 | 2200 X 810 | Same |
| | Range
(mm) | Lateral
±140
Longitudinal
±480 | Lateral
±140
Longitudinal
±480 | Lateral
±125
Longitudinal
±500 | Same &
Differences(6)
Same &
Differences(7) |
| Table
height | Mechanism | DC Motor,
Ball screw | DC Motor,
Ball screw | DC Motor,
Ball screw | Same |
| | Range(mm) | 545 ~ 900 | 545 ~ 900 | 565 ~ 850 | Same &
Differences(8) |
| Horizontal range of
detector(mm) | | 688 | 688 | 290 | Same &
Differences(9) |
| Maximum Patient
Weight(kg) | | 350
(Static, Center
load) | 350
(Static, Center
load) | 300
(Static,
Center load) | Same &
Differences(10) |

| Manufacturer

Contents	GC85A (K160997)	GC70	Discussion
(6) Detector (already cleared with K160997)
Name	S4335-
W	S4343-
W	S3025-
W	S4335-
W	S4343-
W	S3025-
W	Same
MTF	84%
(0.5 lp/mm,
Typical)	85 %
(0.5 lp/mm,
Typical)	86%
(0.5 lp/mm,
Typical)	84%
(0.5 lp/mm,
Typical)	85 %
(0.5 lp/mm,
Typical)	86%
(0.5 lp/mm,
Typical)	Same
DQE	73%
(0.1 lp/mm,
Typical)	80 %
(0.1 lp/mm,
Typical)	78%
(0.1 lp/mm,
Typical)	73%
(0.1 lp/mm,
Typical)	80 %
(0.1 lp/mm,
Typical)	78%
(0.1 lp/mm,
Typical)	Same

6

Image /page/6/Picture/1 description: The image shows the Samsung logo. The logo is white text on a blue background. The text is in a sans-serif font and is slightly italicized.

510(k) Premarket Notification - Traditional

| Manufacturer

Contents	GC85A (K160997)	GC70	Discussion
(8) Software Features (already cleared with K160997)
Feature Names	SimGrid	SimGrid	Same
	Bone Suppression Image	Bone Suppression Image	Same
Description

The SimGrid is an additional image processing software option which is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid.

The Bone Suppression Software features that will be made to Samsung Digital X-ray imaging Systems are adding Samsung's new post image processing algorithm. This SW can provide companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The Bone Suppression software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image.

No	Differences	Explanation
(1)	Appearance	The table and stand of the proposed device is a basic model in
comparison with the predicate device's one, which does not
contribute any adverse impacts to the device's safety and
performance and image quality.
(2)	Max. Power	The difference of max power rate does not contribute any adverse
impacts to the device's safety and performance and image quality.
(3)	Tube Current	The difference of tube current does not contribute any adverse
impacts to the device's safety and performance and image quality.
(4)	Vertical
Movement -
Range	The difference of vertical Moving range does not contribute any
adverse impacts to the device's safety and performance and image
quality.
(5)	Detector - Tilting	The difference of Detector - Tilting does not contribute any adverse
impacts to the device's safety and performance and image quality.
(6)	Table Top -
Lateral	The difference of lateral moving range does not contribute any
adverse impacts to the device's safety and performance and image
quality.
(7)	Table Top -
Longitudinal	The difference of table top longitudinal moving range does not
contribute any adverse impacts to the device's safety and
performance and image quality.
(8)	Table Height -
range	The difference of Table Height - range does not contribute any
adverse impacts to the device's safety and performance and image
quality.
(9)	Horizontal range
of detector.	The difference of horizontal range of detector does not contribute
any adverse impacts to the device's safety and performance and
image quality.
(10)	Maximum Patient
Weight	The difference of maximum patient weight does not contribute any
adverse impacts to the device's safety and performance and image
quality.

B. Difference Table

7

Image /page/7/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is sans-serif and bold, and the letters are evenly spaced. The blue oval is tilted slightly to the left.

510(k) Premarket Notification - Traditional

10. Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1.JEC 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.

11. Non-clinical data

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 proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.

The software contained in the proposed device has been developed & tested in the S/W development procedure on IEC62304, and the Guidance for Content of Premarket Submissions for Software Contained in Medical Devices.

The dosimetry performance has been evaluated with IEC60601-1, and the recommened exposure chart is provided in the user manual.

12. Clinical data

In clinical data, phantom image evaluations were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by a professional radiologist and found to be equivalent to the predicate device.

13. Conclusions

The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.