Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image processing algorithms ("Image Post-processing Engine" or "IPE") for noise reduction and image tuning, but does not mention or imply the use of AI or ML techniques. The focus is on traditional image processing methods and their impact on image quality and dose reduction.

Therapeutic

No.
The device is described as an "X-ray Imaging System" intended for "generating radiographic images of human anatomy." This indicates it is a diagnostic tool used for imaging, not for treating or curing diseases.

Diagnostic

Yes

The device generates radiographic images for human anatomy, which are then processed and sent to PACS for reading. The "Intended Use" states it's for generating images, and the "Device Description" mentions "Samsung Digital Diagnostic X-ray System" and "reading images," indicating its role in providing imagery used for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes hardware components such as an X-ray transmitter, detector, and signal processing hardware (S-station) in addition to the software (IPE).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is used to generate radiographic images of human anatomy by transmitting X-rays through a patient's body. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) diagnostic test.
The device description focuses on image acquisition and processing. The description details how X-rays are captured, converted to electrical signals, processed, and stored as medical images. This aligns with the function of a medical imaging system, not an IVD.
The performance studies evaluate image quality and dose reduction. The studies described assess metrics like CNR, DCC, MTF, and image quality grading scales, which are relevant to the performance of an X-ray imaging system. IVD performance studies would typically involve metrics related to the accuracy and reliability of tests performed on biological samples (e.g., sensitivity, specificity, accuracy).

Therefore, the GC85A, GC70, GU60A & GU60A-65, GF50, GF50A, GR40CW, and GM85 Digital X-ray Imaging Systems are medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 GF50 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 GF50A 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 GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

The GM85 Digital Mobile 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, MOB, IZL

Device Description

GC70, GU60&GU60A-65, GF50, GF50A, GR40CW, GM85 and GC85A are 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 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, SAMSUNG digital X-ray operation software, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.

The IPE operates, from the input image, the roles of a region-of-interest extraction, tone-scale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm (hereinafter "new IPE") is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm (hereinafter "old IPE"), is substantially equivalent. It was cleared with K172229 that using the new IPE is able to reduce dose of 50% for chest PA of average adult in the proposed device, GC85A. The scope of the claim, 50% dose reduction by using the new IPE, was expanded at K180543, from GC85A to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85. In K180543, it was evaluated that the IPE had no relation with imaging chain and the images acquired by a various imaging chain were substantially equivalent to GC85A (K172229).

This submission is purposed to get 510(k) clearance for expanding the scope of the dose reduction claims, the chest PA of average adult to abdominal radiograph of adult, cleared with K172229 and K180543, and chest, abdomen and skull of pediatric populations.

The principles of operation and technological characteristics of the proposed devices and the predicate devices are the same. The proposed device is identical to the predicate devices since there are the same devices including the new IPE; however, Samsung would like to expand dose reduction claims to the adult's abdominal radiograph, and the chest, abdomen and skull of pediatric populations for marketing purposes.

The non-clinical and clinical image evaluations show that the proposed devices with the new IPE employing and advanced noise reduction algorithm are able to reduce x-ray dose up to 47.5% for abdominal radiographs of average adult and up to 45% for pediatric abdomen, 15.5% for pediatric chest, and up to 27% for pediatric skull exams, compared with radiation doses needed to obtain similar image quality using the old IPE on the same x-ray systems.

Note: The dose reduction claim is based on non-clinical (phantom) testing and on clinical testing conducted at one medical site with a specific x-ray imaging system and specific technique factors. In practice, the values of dose reduction may vary accordingly. The clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction. The pediatric subgroup, neonate under 1 month old, was not studied.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy, chest, abdominal, abdomen, skull

Indicated Patient Age Range

Adult, pediatric populations (excluding neonates under 1 month old)

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

Abdominal radiograph for adult:
GC85A as a representative device of the proposed devices was validated with anthropomorphic phantom images and clinical images by three and two professional radiologists respectively. Anthropomorphic phantom images captured at different radiation exposures were scored by the 5-point grading scale in consideration of anatomical regions and physical parameters. Clinical images captured at two different radiation exposures were also scored by the 5-point grading scale for the assessment of overall image quality such as sharpness and visualization for the anatomical regions.

Pediatric population:
GC85A as a representative device of the proposed devices were evaluated using a validated noise simulation tool in pursue of dose optimization with the new IPE relative to the old IPE for chest, abdomen and skull of pediatric populations.
Dose reduction performance was calculated by a statistical method based on a clinical trial. Three experienced pediatric radiologists assessed the series of dose-simulated images to decide the optimal dose for each patient. The optimal dose means the lowest dose at which image quality is still appropriate for diagnosis.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical data:
The quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom taken at a various exposure condition using GM85. Contrast to Noise Ratio (CNR), Detail Compacted Contrast (DCC) and Modulation Transfer Functions (MTF) of the images were measured and compared. As a result of comparison, CNR was measured highly under the condition of the new IPE in comparison with the old IPE and the other image quality metrics such as DCC and MTF of the new IPE were equivalent to those of the old IPE. The non-clinical data shows that images using the new IPE make it easy to distinguish between background and the object, and is clearer than images using the old IPE. Ant it says that the performance of the new IPE is robustness with regard to the variation of X-ray exposure factors such as kVp values and 0.1 mm Cu filter on/off.

Clinical data:
i. Abdominal radiograph for adult
The anthropomorphic phantom image study shows that the new IPE with an advanced noise reduction algorithm retained the quality of images captured at 47.5% reduced exposure in comparison with the old IPE. In detail, we performed a paired t-test comparison between each lower dose image and the reference image; the old IPE maintained the image quality at as low as 0.4 mGy, while the new IPE maintained the image quality at as low as 0.21 mGy. We derived the dose reduction 47.5% by calculating (0.4-0.21)/0.4*100. We confirmed that it was possible to reduce the dose in clinical images as well.
Based on the evaluation of anthropomorphic phantom images, the new IPE enables to reduce the dose of 47.5%.

ii. Pediatric population
On the whole, image processed by new IPE could achieve lower optimal dose than the old IPE. We analyzed the difference between the optimal doses for old IPE and new IPE images.
Based on the evaluation, the performance of the new IPE shows that the images using the new IPE taken at up to 45% reduction for pediatric abdomen. 15.5% for pediatric chest, and up to 27% pediatric skull in radiation dose are substantially equivalent of those using the old IPE without sacrificing diagnostic confidence, although dose reduction rate is various in accordance with protocols such as chest, abdomen and skull and pediatric sub-population.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Dose reduction:
Up to 47.5% for abdominal radiographs of adult
Up to 45% for pediatric abdomen
15.5% for pediatric chest
Up to 27% for pediatric skull

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.

K180543, K181631, K181626, K181629

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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.

December 7, 2018

Samsung Electronics Co., LTD. Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-Ro, Yeongtong-Gu Suwon-Si, 16677 Republic of Korea

Re: K182183

Trade/Device Name: GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR, MOB, IZL Dated: July 31, 2018 Received: August 13, 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 vou, 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,

Hol. 2. Nils

Robert A. Ochs, 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) K182183

Device Name

GC85A

Indications for Use (Describe)

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.

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

"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)

PRAStaff@fda.hhs.gov

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

PSC Publishing Services (301) 443-6740 EF

3

Indications for Use

510(k) Number (if known) K182183

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 Drug 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."

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

4

Indications for Use

510(k) Number (if known) K182183

Device Name GU60A, GU60A-65

Indications for Use (Describe)

The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 Drug 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."

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

5

Indications for Use

510(k) Number (if known) K182183

Device Name GF50

Indications for Use (Describe)

The GF50 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

Department of Health and Human Services Food and Drug 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)

6

Indications for Use

510(k) Number (if known) K182183

Device Name GF50A

Indications for Use (Describe)

The GF50A 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 Drug 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."

7

Indications for Use

510(k) Number (if known)

K182183

Device Name GR40CW

Indications for Use (Describe)

The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. 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 Drug 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."

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

8

Indications for Use

510(k) Number (if known) K182183

Device Name GM85

Indications for Use (Describe)

The GM85 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 Drug 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."

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

9

Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo is in blue and the word "SAMSUNG" is written in white, bold letters. The logo 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: July 31, 2018

2. Submitter

A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, B. Republic of Korea

3. Primary Contact Persons

A. Name: JAESANG NOH & CHULSIN KIM
B. Title: Regulatory Affairs Senior Professional
Phone Number: +82-2-2193-2444 & +82-2-2193-2437 ﻥ
D. FAX Number: +82-31-200-6401 E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com

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

5. Proposed Device

	#1	#2	#3	#4	#5	#6	#7
Trade
Name	GC70	GU60A&
GU60A-
65	GF50	GF50A	GR40C
W	GM85	GC85A
Device
Name	GC70	GU60A&
GU60A-
65	GF50	GF50A	GR40C
W	GM85	GC85A
Common
Name	Digital
Diagnos
tic X-ray
System	Digital
Diagnos
tic X-ray
System	Digital
Diagnos
tic X-ray
System	Digital
Diagnos
tic X-ray
System	Retrofit
Kit	Digital
Diagnos
tic
Mobile
X-ray
System	Digital
Diagnos
tic X-ray
System
Regulation
Name	Stationar
y X-ray
System	Stationar
y X-ray
System	Stationar
y X-ray
System	Stationar
y X-ray
System	Stationar
y X-ray
System	Mobile
X-ray
System	Stationar
y X-ray
System
Product
Code	KPR	KPR	KPR	KPR	MQB	IZL	KPR

10

Image /page/10/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

| Regulation | 21 CFR
892.168
0 | 21 CFR
892.168
0 | 21 CFR
892.168
0 | 21 CFR
892.168
0 | 21 CFR
892.168
0 | 21 CFR
892.172
0 | 21 CFR
892.168
0 |

------------	------------------------	------------------------	------------------------	------------------------	------------------------	------------------------	------------------------

6. Predicate Devices

		Predicate Devices
	#1	#2	#3	#4	#5	#6	#7
Device
Name	GC70	GU60A&
GU60A-
65	GF50	GF50A	GR40C
W	GM85	GC85A
Classificati
on Name	Stationar
y X-ray
System	Stationar
y X-ray
System	Stationar
y X-ray
System	Stationar
y X-ray
System	Solid
State X-
ray
Imager	Mobile
X-ray
System	Stationar
y X-ray
System
Product
Code	KPR	KPR	KPR	KPR	MQB	IZL	KPR
Regulation	21 CFR
892.168
0	21 CFR
892.168
0	21 CFR
892.168
0	21 CFR
892.168
0	21 CFR
892.168
0	21 CFR
892.172
0	21 CFR
892.168
0
510(K)#	K180543	K180543	K180543	K180543	K181631	K181626	K181629
510(K)
Decision
Date	May 24,
2018	May 24,
2018	May 24,
2018	May 24,
2018	July 20,
2018	July 20,
2018	July 20,
2018

7. Device Description

GC70, GU60&GU60A-65, GF50, GF50A, GR40CW, GM85 and GC85A are 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 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, SAMSUNG digital X-ray operation software, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.

The IPE operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm (hereinafter "new IPE") is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm (hereinafter "old IPE"), is substantially equivalent. It was cleared with K172229 that using the new IPE is able to reduce dose of 50% for chest PA of average adult in the proposed device, GC85A. The scope of the claim, 50% dose reduction by using the new IPE, was expanded at K180543, from GC85A to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85. In K180543, it was evaluated that the IPE had no relation with imaging chain and the images acquired by a various imaging chain were substantially equivalent to GC85A (K172229).

11

Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo is in blue and features the word "SAMSUNG" in bold, white letters. The word is slightly tilted to the right and is enclosed in an elliptical shape.

510(k) Premarket Notification - Traditional

This submission is purposed to get 510(k) clearance for expanding the scope of the dose reduction claims, the chest PA of average adult to abdominal radiograph of adult, cleared with K172229 and K180543, and chest, abdomen and skull of pediatric populations.

The principles of operation and technological characteristics of the proposed devices and the predicate devices are the same. The proposed device is identical to the predicate devices since there are the same devices including the new IPE; however, Samsung would like to expand dose reduction claims to the adult's abdominal radiograph, and the chest, abdomen and skull of pediatric populations for marketing purposes.

The non-clinical and clinical image evaluations show that the proposed devices with the new IPE employing and advanced noise reduction algorithm are able to reduce x-ray dose up to 47.5% for abdominal radiographs of average adult and up to 45% for pediatric abdomen, 15.5% for pediatric chest, and up to 27% for pediatric skull exams, compared with radiation doses needed to obtain similar image quality using the old IPE on the same x-ray systems.

Note: The dose reduction claim is based on non-clinical (phantom) testing and on clinical testing conducted at one medical site with a specific x-ray imaging system and specific technique factors. In practice, the values of dose reduction may vary accordingly. The clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction. The pediatric subgroup, neonate under 1 month old, was not studied.

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.

The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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.

GF50 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 GF50A 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 GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.

The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This

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Image /page/12/Picture/1 description: The image features the word "SAMSUNG" in bold, white letters against a blue, rounded background. The font is sans-serif and the letters are evenly spaced. The blue background is a rounded shape, resembling an oval or elongated circle, and it provides a contrasting backdrop that makes the white text stand out.

510(k) Premarket Notification - Traditional

device is not intended for mammographic applications.

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.

1. Summary of Technological characteristic of the proposed devices compared with the predicate devices
  The proposed devices, GC70, GU60&GU60A-65, GF50, GF50A, GR40CW, GM85 and GC85A, are identical to the predicate devices recently cleared with K180543 (GC70, GU60&GU60A-65, GF50 and GF50A), K181631 (GR40CW), K181626 (GM85) and K181629 (GC85A), including the new IPE with employing an advanced noise reduction algorithm.

Specification	Proposed Device #1	Predicate Device #1 (PD #1)	Discussion
Device Name	GC70	GC70
Manufacturer	SAMSUNG ELECTRONICS Co., Ltd.	SAMSUNG ELECTRONICS Co., Ltd.
510(k) Number	None	K180543
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.	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#1
High Voltage Generator
Type	High Frequency	High Frequency	Same as PD#1
Max. Power	82kW	82kW	Same as PD#1
Output Range	Tube Voltage
40-150kV	Tube Voltage
40-150kV	Same as PD#1
	Tube Current
10-1000mA	Tube Current
10-1000mA	Same as PD#1
	Exposure Time
1msec-10sec	Exposure Time
1msec-10sec	Same as PD#1
AEC (Automatic Exposure Control)	Yes	Yes	Same as PD#1

A. Compared with Predicate Devices

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Image /page/13/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.

| APR
(Anatomically
Programmed

Radiography)			Yes			Yes
X-ray tube
	Name	E7869X	E7252X	E7869X	E7252X	Same as PD#1
	kV range	40-150kV	40-150kV	40-150kV	40-150kV	Same as PD#1
Max.
Power	Large focus	100kW	75kW	100kW	75kW	Same as PD#1
	Small focus	40kW	27kW	40kW	27kW	Same as PD#1
Max.
mA	Large focus	1000mA	1000mA	1000mA	1000mA	Same as PD#1
	Small focus	500mA	400mA	500mA	400mA	Same as PD#1
	Anode target
material	Rhenium-
Tungsten	Rhenium-
Tungsten	Rhenium-
Tungsten	Rhenium-
Tungsten	Same as PD#1
Collimator
	Name	SDR-OGCL83U	SDR-OGCL83U	Same as PD#1
	Overall
Size(mm)	H212 X W306
X D179	H212 X W306
X D179	Same as PD#1
	Beam Limiting
Blade
Moving Method		Motorized
/Manual	Motorized
/Manual	Same as PD#1
	Manual
Operation
Method		Volume	Volume	Same as PD#1
Collimator
Rotation		±45	±45	Same as PD#1
	Beam Light
Source	LED	LED	Same as PD#1
	Light Field
Indicator Timer	O	O	Same as PD#1
		O	O	Same as PD#1
	Side Lamp	Laser Module	Laser Module	Same as PD#1
	Field Size / SID
Display	Color LCD	Color LCD	Same as PD#1
Detector
	Name	S433
5-W	S434
3-W	S302
5-W	S433
5-W	S434
3-W	S302
5-W	Same as PD#1
		Csl	Csl	Csl	Csl	Csl	Csl	Same as PD#1
	Detector Type	Indirect	Indirect	Indirect	Indirect	Indirect	Indirect	Same as PD#1
	Detector Area	14"X1
7"
(345 mmX
425m m)	17"X1
7"
(425 mmX
425m m)	10"X1
2"
(245 mmX
295m m)	14"X1
7"
(345 mmX
425m m)	17"X1
7"
(425 mmX
425m m)	10"X1
2"
(245 mmX
295m m)	Same as PD#1
	Number of
pixels	2466
X3040	3036
X3040	1750
X2108	2466
X3040	3036
X3040	1750
X2108	Same as PD#1

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Image /page/14/Picture/1 description: The image shows the SAMSUNG logo in white text on a blue background. The logo is stylized with a slightly tilted, oval shape. The text is bold and sans-serif. The overall impression is clean and modern.

Pixel Pitch(um)	140	140	140	140	140	140	Same as PD#1
High Contrast
Limiting
Resolution
(LP/mm)	3.57	3.57	3.57	3.57	3.57	3.57	Same as PD#1
Communication	Wired /
Wirel
ess	Wired /
Wirel
ess	Wired /
Wirel
ess	Wired /
Wirel
ess	Wired /
Wirel
ess	Wired /
Wirel
ess	Same as PD#1
Image Post-processing Engine
Noise reduction
algorithm	Image Post-
processing Engine
with an advanced
noise reduction
algorithm						Same as PD#1
Claim of dose
reduction	50% dose reduction
for chest PA of
average adult						Same as PD #1
	Up to 47.5% dose
reduction for
abdominal
radiographs of adult						Different(1)
	Up to 45% dose
reduction for pediatric
abdomen, 15.5% for
pediatric chest, and
up to 27% for pediatric
skull exams						Different(2)

| Specification | Proposed Device #2 | | Predicate Device #2
(PD #2) | | Discussion | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------|-------------------|---------------|
| | GU60A | GU60A-65 | GU60A | GU60A-65 | | | |
| Device Name | GU60A & GU60A-65 | | GU60A & GU60A-65 | | | | |
| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | | SAMSUNG
ELECTRONICS Co.,
Ltd. | | | | |
| 510(k) Number | None | | K180543 | | | | |
| Intended Use | The GU60A &
GU60A-65 Digital X-
ray Imaging Systems
are 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 GU60A &
GU60A-65 Digital X-
ray Imaging Systems
are 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 | | |
| High Voltage Generator
Type | High Frequency | | High Frequency | | Same as PD#2 | | |
| | Max. Power | 50kW/68kW | 65kW | 50kW/68kW | 65kW | Same as PD#2 | |
| | Tube
Voltage | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | Same as PD#2 | |
| Output
RANGE | Tube
Current | 10 - 630mA/
10 - 800mA | 10 - 800mA | 10 - 630mA/
10 - 800mA | 10 - 800mA | Same as PD#2 | |
| | Exposure
Time | 1msec-
6.3sec/
1msec-
10sec | 1msec-
6.3sec | 1msec-
6.3sec/
1msec-
10sec | 1msec-
6.3sec | Same as PD#2 | |
| X-ray tube | | | | | | | |
| | Name | E7252X | | E7252X | | Same as PD#2 | |
| | kV range | 40-150kV | | 40-150kV | | Same as PD#2 | |
| Max.
Power | Large
focus | 75kW | | 75kW | | Same as PD#2 | |
| r | Small
focus | 27kW | | 27kW | | Same as PD#2 | |
| Max.
mA | Large
focus | 1000mA | | 1000mA | | Same as PD#2 | |
| | Small
focus | 400mA | | 400mA | | Same as PD#2 | |
| Anode target
material | | Rhenium-Tungsten | | Rhenium-Tungsten | | Same as PD#2 | |
| Collimator | | | | | | | |
| | Name | SDR-OGCL82U | | SDR-OGCL82U | | Same as PD#2 | |
| | Overall
Size(mm) | H212 X W306
X D179 | | H212 X W306
X D179 | | Same as PD#2 | |
| | Beam Limiting
Blade
Moving Method | Motorized
/Manual | | Motorized
/Manual | | Same as PD#2 | |
| | Manual
Operation
Method | Volume | | Volume | | Same as PD#2 | |
| | Collimator
Rotation | ±45 | | ±45 | | Same as PD#2 | |
| | Beam Light
Source | LED | | LED | | Same as PD#2 | |
| | Light Field
Indicator Timer | O | | O | | Same as PD#2 | |
| | Side Lamp | Laser Module | | Laser Module | | Same as PD#2 | |
| | Field Size / SID
Display | Color LCD | | Color LCD | | Same as PD#2 | |
| Detector | | | | | | | |
| | Name | S433
5-W | S434
3-W | S302
5-W | S433
5-W | Same as PD#2 | |
| | | Csl | Csl | Csl | Csl | Same as PD#2 | |
| | 14"X | 17"X | 10"X1 | 14"X | 17"X1 | 10"X1 | |
| | 17" | 17" | 2" | 17" | 7" | 2" | |
| | (345 | (425 | (245 | (345 | (425 | (245 | |
| Detector Area | mmX | mmX | mmX | mmX | mmX | mmX | Same as PD#2 |
| | 425m | 425m | 295m | 425m | 425m | 295m | |
| | m) | m) | m) | m) | m) | m) | |
| | 2466 | 3036 | 1750 | 2466 | 3036 | 1750 | |
| Number of | X304 | X304 | X210 | X304 | X304 | X210 | Same as PD#2 |
| pixels | 0 | 0 | 8 | 0 | 0 | 8 | |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#2 |
| High Contrast | | | | | | | |
| Limiting | | | | | | | |
| Resolution | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#2 |
| (LP/mm) | | | | | | | |
| | Wired | Wired | Wired | Wired | Wired | Wired | |
| Communication | / | / | / | / | / | / | Same as PD#2 |
| | Wirel | Wirel | Wirel | Wirel | Wirel | Wirel | |
| | ess | ess | ess | ess | ess | ess | |
| Image Post-processing Engine | | | | | | | |
| Noise reduction | Image Post- | Image Post- | Image Post- | Image Post- | Image Post- | Image Post- | Same as PD#2 |
| algorithm | processing Engine | processing Engine | processing Engine | processing Engine | processing Engine | processing Engine | |
| | with an advanced | with an advanced | with an advanced | with an advanced | with an advanced | with an advanced | |
| | noise reduction | | | | noise reduction | | |
| | algorithm | algorithm | algorithm | algorithm | algorithm | algorithm | |
| | | 50% dose reduction | | | 50% dose reduction | | Same as PD #2 |
| | | for chest PA of | | | for chest PA of | | |
| | | average adult | | | average adult | | |
| | | Up to 47.5% dose | - | | - | | Different(1) |
| | reduction for | | | | | | |
| Claim of dose | abdominal | | | | | | |
| reduction | radiographs of adult | | | | | | |
| | | Up to 45% dose | - | | - | | Different(2) |
| | | reduction for pediatric | | | | | |
| | | abdomen, 15.5% for | | | | | |
| | | pediatric chest, and | | | | | |
| | | up to 27% for pediatric | | | | | |
| skull exams | | | | | | | |

15

Image /page/15/Picture/1 description: The image shows the SAMSUNG logo. The logo is white text on a blue background. The background is an oval shape.

16

Image /page/16/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.

| Specification | Proposed Device #3 | Predicate Device #3
(PD #3) | Discussion | |
|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------|
| Device Name | GF50 | GF50 | | |
| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | SAMSUNG
ELECTRONICS Co.,
Ltd. | | |
| 510(k) Number | None | K180543 | | |
| Intended Use | The GF50 Digital X-
ray Imaging System is
intended for use in
generating
radiographic images
of human anatomy by
a qualified/trained | The GF50 Digital X-
ray Imaging System is
intended for use in
generating
radiographic images
of human anatomy by
a qualified/trained | Same as PD#3 | |
| doctor or technician.
This device is not
intended for
mammographic
applications. | | | doctor or technician.
This device is not
intended for
mammographic
applications. | |
| High Voltage Generator | Type | High Frequency | High Frequency | Same as PD#3 |
| | Max. Power | 52kW | 52kW | Same as PD#3 |
| Output
RANG
E | Tube
Voltag
e | 40-150kV | 40-150kV | Same as PD#3 |
| | Tube
Curren
t | 10-640mA | 10-640mA | Same as PD#3 |
| | Expos
ure
Time | 1msec-10sec | 1msec-10sec | Same as PD#3 |
| | AEC
(Automatic
Exposure
Control) | Yes | Yes | Same as PD#3 |
| | APR
(Anatomically
Programmed
Radiography) | Yes | Yes | Same as PD#3 |
| X-ray tube | | | | |
| | Name | E7252X | E7252X | Same as PD#3 |
| | kV range | 40-150kV | 40-150kV | Same as PD#3 |
| Max.
Powe
r | Large
focus | 75kW | 75kW | Same as PD#3 |
| | Small
focus | 27kW | 27kW | Same as PD#3 |
| Max.
mA | Large
focus | 1000mA | 1000mA | Same as PD#3 |
| | Small
focus | 400mA | 400mA | Same as PD#3 |
| | Anode target
material | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#3 |
| Collimator | | | | |
| | Name | SDR-OGCL50D | SDR-OGCL50D | Same as PD#3 |
| | Overall
Size(mm) | H185 X W213
X D180 | H185 X W213
X D180 | Same as PD#3 |
| | Beam Limiting
Blade
Moving Method | Manual | Manual | Same as PD#3 |
| | Manual
Operation
Method | Volume | Volume | Same as PD#3 |
| | Collimator
Rotation | ±45 | ±45 | Same as PD#3 |
| Light Field
Indicator Timer | O | O | Same as PD#3 | |
| | O | O | Same as PD#3 | |
| Side Lamp | Laser Module | Laser Module | Same as PD#3 | |
| Field Size / SID
Display | Color LCD | Color LCD | Same as PD#3 | |
| Detector | | | | |
| Name | S4335-W | S4335-W | Same as PD#3 | |
| Detector Type | Csl | Csl | Same as PD#3 | |
| | Indirect | Indirect | Same as PD#3 | |
| Detector Area | 14"X17"
(345mmX425mm) | 14"X17"
(345mmX425mm) | Same as PD#3 | |
| Number of
pixels | 2466X3040 | 2466X3040 | Same as PD#3 | |
| Pixel Pitch(um) | 140 | 140 | Same as PD#3 | |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.5 | 3.5 | Same as PD#3 | |
| Communication | Wired / Wireless | Wired / Wireless | Same as PD#3 | |
| Image Post-processing Engine | | | | |
| Noise reduction
algorithm | Image Post-
processing Engine
with an advanced | Image Post-
processing Engine
with an advanced | Same as PD#3 | |
| | noise reduction
algorithm | noise reduction
algorithm | | |
| | 50% dose reduction
for chest PA of
average adult | 50% dose reduction
for chest PA of
average adult | Same as PD #3 | |
| Claim of dose | Up to 47.5% dose
reduction for
abdominal
radiographs of adult | - | Different(1) | |
| reduction | Up to 45% dose
reduction for pediatric
abdomen, 15.5% for
pediatric chest, and
up to 27% for pediatric
skull exams | - | Different(2) | |

17

Image /page/17/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a blue background. The word is in all capital letters and is in a sans-serif font. The blue background is in the shape of an oval. The logo is simple and recognizable.

18

Image /page/18/Picture/1 description: The image contains the word "SAMSUNG" in white font on a blue background. The word is written in all capital letters and is centered in the image. The background is a rounded rectangle shape.

| Specification | Proposed Device #4 | Predicate Device #4
(PD #4) | Discussion | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name | GF50A | GF50A | | |
| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | SAMSUNG
ELECTRONICS Co.,
Ltd. | | |
| 510(k) Number | None | K180543 | | |
| Intended Use | | The GF50A 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 GF50A 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#4 |
| High | Voltage Generator | | | |
| | Type | High Frequency | High Frequency | Same as PD#4 |
| | Max. Power | 40kW | 40kW | Same as PD#4 |
| | Tube
Voltag
e | 40-125kV | 40-125kV | Same as PD#4 |
| Output
RANG
E | Tube
Curren
t | 10-500mA | 10-500mA | Same as PD#4 |
| | Expos
ure
Time | 1msec-10sec | 1msec-10sec | Same as PD#4 |
| | AEC
(Automatic
Exposure
Control) | Yes | Yes | Same as PD#4 |
| APR
(Anatomically
Programmed
Radiography) | | Yes | Yes | Same as PD#4 |
| X-ray tube | | | | |
| Name | | E7252X | E7252X | Same as PD#4 |
| | kV range | 40-150kV | 40-150kV | Same as PD#4 |
| Max.
Powe
r | Large
focus | 75kW | 75kW | Same as PD#4 |
| | Small
focus | 27kW | 27kW | Same as PD#4 |
| Max.
mA | Large
focus | 1000mA | 1000mA | Same as PD#4 |
| | Small
focus | 400mA | 400mA | Same as PD#4 |
| | Anode target
material | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#4 |
| Collimator | | | | |
| | Name | SDR-OGCL50D | SDR-OGCL50D | Same as PD#4 |
| | Overall
Size(mm) | H185 X W213
X D180 | H185 X W213
X D180 | Same as PD#4 |
| Beam Limiting
Blade
Moving Method | | Manual | Manual | Same as PD#4 |
| Manual
Operation
Method | Volume | Volume | Same as PD#4 | |
| Collimator
Rotation | $\pm$ 90 | $\pm$ 90 | Same as PD#4 | |
| Beam Light
Source | Halogen Lamp | Halogen Lamp | Same as PD#4 | |
| Light Field
Indicator Timer | O | O | Same as PD#4 | |
| Side Lamp | Laser Module | Laser Module | Same as PD#4 | |
| Field Size / SID
Display | Color LCD | Color LCD | Same as PD#4 | |
| Detector | | | | |
| Name | S4335-W | S4335-W | Same as PD#4 | |
| Detector Type | Csl
Indirect | Csl
Indirect | Same as PD#4 | |
| Detector Area | 14"X17"
(345mmX425mm) | 14"X17"
(345mmX425mm) | Same as PD#4 | |
| Number of
pixels | 2466X3040 | 2466X3040 | Same as PD#4 | |
| Pixel Pitch(um) | 140 | 140 | Same as PD#4 | |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.5 | 3.5 | Same as PD#4 | |
| Communication | Wired / Wireless | Wired / Wireless | Same as PD#4 | |
| Image Post-processing Engine | | | | |
| Noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Same as PD#4 | |
| Claim of dose
reduction | 50% dose reduction
for chest PA of
average adult | 50% dose reduction
for chest PA of
average adult | Same as PD #4 | |
| | Up to 47.5% dose
reduction for
abdominal
radiographs of adult | - | Different(1) | |
| | Up to 45% dose
reduction for pediatric
abdomen, 15.5% for
pediatric chest, and
up to 27% for pediatric
skull exams | - | Different(2) | |

19

Image /page/19/Picture/1 description: The image features the word "SAMSUNG" in bold, white letters against a solid blue background. The font is sans-serif and appears to be a custom typeface. The logo is simple and modern, with a clean design that is easily recognizable.

20

Image /page/20/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a blue background. The font is bold and sans-serif. The word is slightly angled, with the right side appearing lower than the left.

| Specification | Proposed Device #5 | Predicate Device #5
(PD #5) | Discussion |
|---------------|--------------------|--------------------------------|------------|
| Device Name | GR40CW | GR40CW | |

21

Image /page/21/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a dark blue oval shape.

| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | | SAMSUNG
ELECTRONICS Co., Ltd. | | | | | | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|--------------|
| 510(k) Number | None | | | K181631 | | | | | |
| Intended Use | The GR40CW Digital
X-ray Imaging System
is intended for use in
general projection
radiographic
applications wherever
conventional screen-
film systems or CR
systems may be used.
This device is not
intended for
mammographic
applications. | | The GR40CW Digital
X-ray Imaging System
is intended for use in
general projection
radiographic
applications wherever
conventional screen-
film systems or CR
systems may be
used. This device is
not intended for
mammographic
applications. | | | | Same as PD#5 | | |
| Detector | | | | | | | | | |
| Name | S43
35-
W/
S43
35-
AW | S43
35-
WV/
S43
35-
AW
V | S43
43-
W/
S43
43-
AW | S30
25-
W | S43
35-
W/
S43
35-
AW | S43
35-
WV/
S43
35-
AW
V | S43
43-
W/
S43
43-
AW | S30
25-
W | Same as PD#5 |
| Detector Type | CsI | Gd₂
O₂
S | CsI | CsI | CsI | Gd₂
O₂
S | CsI | CsI | Same as PD#5 |
| | Indi
rect | Indi
rect | Indi
rect | Indi
rect | Indi
rect | Indi
rect | Indi
rect | Indi
rect | Same as PD#5 |
| Detector Area | 14"
X17
"(3
45
mm
X42
5m
m) | 14"
X17
"
(34
5m
mX
425
mm | 17"
X17
"
(42
5m
mX
425
mm | 10"
X12
"
(24
5m
mX
295
mm | 14"
X1
7"(
345
mm
X4
25
mm | 14"
X1
7"
(34
5m
mX
425
mm | 17"
X1
7"
(42
5m
mX
425
mm | 10"
X1
2"
(24
5m
mX
295
mm | Same as PD#5 |
| Number of
pixels | 246
6X3
040 | 246
6X3
040 | 303
6X3
040 | 175
0X2
108 | 246
6X
304
0 | 246
6X
304
0 | 303
6X
304
0 | 175
0X
210
8 | Same as PD#5 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#5 |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.5
7 | 3.5 | 3.5
7 | 3.5
7 | 3.5
7 | 3.5 | 3.5
7 | 3.5
7 | Same as PD#5 |
| Communication | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Wir
ed /
Wir
ele
ss | Same as PD#5 |

22

Image /page/22/Picture/1 description: The image features the SAMSUNG logo. The logo is displayed in white text against a blue background. The text is bold and sans-serif.

| Noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Same as PD#5 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------------|
| Claim of dose
reduction | 50% dose reduction
for chest PA of
average adult | 50% dose reduction
for chest PA of
average adult | Same as PD #5 |
| | Up to 47.5% dose
reduction for
abdominal
radiographs of adult | - | Different(1) |
| | Up to 45% dose
reduction for pediatric
abdomen, 15.5% for
pediatric chest, and up
to 27% for pediatric
skull exams | - | Different(2) |

| Specification | Proposed Device #6 | Predicate Device #6
(PD #6) | Discussion | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| Device Name | GM85 | GM85 | | |
| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | SAMSUNG
ELECTRONICS Co.,
Ltd. | | |
| 510(k) Number | None | K181626 | | |
| Intended Use | The GM85 Digital
Mobile 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 GM85 Digital
Mobile 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#6 | |
| High Voltage Generator | | | | |
| Type | High Frequency | High Frequency | Same as PD#6 | |
| Max. Power | 32kW / 40kW | 32kW / 40kW | Same as PD#6 | |
| Tube
Voltag
e | 40 to 150kVp | 40 to 150kVp | Same as PD#6 | |
| Output
RANG
E | Tube
Curren
t | 10 - 500mA | 10 - 500mA | Same as PD#6 |
| | Expos
ure
Time | 1msec-10sec | 1msec-10sec | Same as PD#6 |
| AEC
(Automatic | | No | No | Same as PD#6 |

23

Image /page/23/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.

| Exposure

Control)
APR
(Anatomically
Programmed
Radiography)		Yes			Yes				Same as PD#6
	X-ray tube
	Name	XRR-
3332X	LUC-13L	XRR-
3332X	LUC-13L	Same as PD#6
	kV range	40-150kV	40-150kV	40-150kV	40-150kV	Same as PD#6
Max.
Powe	Large
focus	46kW	45kW	46kW	45kW	Same as PD#6
r	Small
focus	20kW	19kW	20kW	19kW	Same as PD#6
Max.	Large
focus	600mA	600mA	600mA	600mA	Same as PD#6
mA	Small
focus	300mA	260mA	300mA	260mA	Same as PD#6
	Anode target
material	Rhenium-
Tungsten	Rhenium-
Tungsten	Rhenium-
Tungsten	Rhenium-
Tungsten	Same as PD#6
	Collimator
	Name	SDR-
OGCL40
U	SDR-
OGCL41
U	SDR-
OGCL40
U	SDR-
OGCL41
U	Same as PD#6
	Overall
Size(mm)	H212 X
W306
X D179	H222 X
W271
X D140	H212 X
W306
X D179	H222 X
W271
X D140	Same as PD#6
	Beam Limiting
Blade
Moving Method	Motorized
/Manual	Manual	Motorized
/Manual	Manual	Same as PD#6
	Manual
Operation
Method	Volume	Volume	Volume	Volume	Same as PD#6
	Collimator
Rotation	+90/-180	+90/-90	+90/-180	+90/-90	Same as PD#6
	Beam Light
Source	LED	LED	LED	LED	Same as PD#6
	Light Field
Indicator Timer	O	O	O	O	Same as PD#6
		O	O	O	O	Same as PD#6
	Side Lamp	Laser
Module	Laser
Module	Laser
Module	Laser
Module	Same as PD#6
	Field Size / SID
Display	Color
LCD	Scale
Mark	Color
LCD	Scale
Mark	Same as PD#6
	Detector
	Name	S4335-
W/
S4335-
AW	S4343-
W/
S4343-
AW	S302
5-W	S4335-
W/
S4335-
AW	S4343-
W/
S4343-
AW	S302
5-W	Same as PD#6
		Csl	Csl	Csl	Csl	Csl	Csl	Same as PD#6
	Detector Type	Indire
ct	Indire
ct	Indire
ct	Indire
ct	Indire
ct	Indire
ct	Same as PD#6

24

Image /page/24/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.

| | 14"X
17"
(345
mmX
425m
m) | 17"X
17"
(425
mmX
425m
m) | 10"X1
2"
(245
mmX
295m
m) | 14"X
17"
(345
mmX
425m
m) | 17"X
17"
(425
mmX
425m
m) | 10"X1
2"
(245
mmX
295m
m) | |
|----------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|---------------|
| Detector Area | 2466
X304
0 | 3036
X304
0 | 1750
X210
8 | 2466
X304
0 | 3036
X304
0 | 1750
X210
8 | Same as PD#6 |
| Number of
pixels | | | | | | | Same as PD#6 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#6 |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#6 |
| Communication | Wired /
Wirel
ess | Wired /
Wirel
ess | Wired /
Wirel
ess | Wired /
Wirel
ess | Wired /
Wirel
ess | Wired /
Wirel
ess | Same as PD#6 |
| Image Post-processing Engine | | | | | | | |
| Noise reduction
algorithm | | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | | | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | | Same as PD#6 |
| | | 50% dose reduction
for chest PA of
average adult | | | 50% dose reduction
for chest PA of
average adult | | Same as PD #6 |
| Claim of dose
reduction | | Up to 47.5% dose
reduction for
abdominal
radiographs of adult | - | | | | Different(1) |
| | | Up to 45% dose
reduction for pediatric
abdomen, 15.5% for
pediatric chest, and
up to 27% for pediatric
skull exams | - | | | | Different(2) |

| Specification | Proposed Device #7 | Predicate Device #7
(PD #7) | Discussion |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name | GC85A | GC85A | |
| Manufacturer | SAMSUNG
ELECTRONICS Co.,
Ltd. | SAMSUNG
ELECTRONICS Co.,
Ltd. | |
| 510(k) Number | None | K181629 | |
| Intended Use | The GM85 Digital
Mobile X-ray imaging
System is intended for
use in generating
radiographic images
of human anatomy by
a qualified/trained | The GC85A Digital X-
ray Imaging System is
intended for use in
generating
radiographic images
of human anatomy by
a qualified/trained | Same as PD#7 |

25

Image /page/25/Picture/1 description: The image features the SAMSUNG logo. The logo is in white text on a blue background. The text is in a bold, sans-serif font.

| | | | doctor or technician.
This device is not
intended for
mammographic
applications. | | doctor or technician.
This device is not
intended for
mammographic
applications. | | Same as PD#7 | | | |
|-----------------------------------------|----------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------|--------------------------|----------------------------------------------------------------------------------------------|--------------------------|-------------------------|--------------------------|-------------------------|--------------|
| High | Voltage Generator | Type | High Frequency | High Frequency | Same as PD#7 | | | | | |
| Max. Power | | 82kW | 52kW | 80kW | 50kW | 82kW | 52kW | 80kW | 50kW | Same as PD#7 |
| Tube
Voltage | | 40-150kV | v40-150kV | 40-150kV | 40-150kV | 40-150kV | v40-150kV | 40-150kV | 40-150kV | Same as PD#7 |
| Output
RANGE | Tube
Current | 10-100
0mA | 10-640
mA | 10-100
0mA | 10-630
mA | 10-100
0mA | 10-640
mA | 10-100
0mA | 10-630
mA | Same as PD#7 |
| | Exposure
Time | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | 1ms
ес-
10s
ec | Same as PD#7 |
| | AEC
(Automatic
Exposure
Control) | | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same as PD#7 |
| | APR
(Anatomically
Programmed
Radiography) | | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same as PD#7 |
| | X-ray tube | | | | | | | | | |
| | Name | E7869X | E7252X | E7869X | E7252X | Same as PD#7 | | | | |
| | kV range | 40-150kV | 40-150kV | 40-150kV | | 40-150kV | | Same as PD#7 | | |
| Max.
Power | Large
focus | 100kW | | 75kW | | 100kW | | 75kW | | Same as PD#7 |
| | Small
focus | 40kW | | 27kW | | 40kW | | 27kW | | Same as PD#7 |
| Max.
mA | Large
focus | 1000mA | | 1000mA | | 1000mA | | 1000mA | | Same as PD#7 |
| | Small
focus | 500mA | | 400mA | | 500mA | | 400mA | | Same as PD#7 |
| | Anode target
material | Rhenium-
Tungsten | | Rhenium-
Tungsten | | Rhenium-
Tungsten | | Rhenium-
Tungsten | | Same as PD#7 |
| Collimator | | | | | | | | | | |
| | Name | SDR-
OGCL80
U | | SDR-
OGCL83
U | | SDR-
OGCL80
U | | SDR-
OGCL83
U | | Same as PD#7 |
| Overall
Size(mm) | | H212 X
W300
X D179 | | H212 X
W306
X D179 | | H212 X
W300
X D179 | | H212 X
W306
X D179 | | Same as PD#7 |
| Beam Limiting
Blade
Moving Method | | Motorized
/Manual | | Motorized
/Manual | | Motorized
/Manual | | Motorized
/Manual | | Same as PD#7 |
| Manual
Operation
Method | | Volume | | Volume | | Volume | | Volume | | Same as PD#7 |

26

Image /page/26/Picture/1 description: The image features the SAMSUNG logo. The logo is displayed in white text against a blue oval background. The word "SAMSUNG" is written in a bold, sans-serif font.

510(k) Premarket Notification - Traditional
Collimator Rotation	±45	±45	±45	±45	±45	Same as PD#7
Beam Light Source	LED	LED	LED	LED	LED	Same as PD#7
Light Field Indicator Timer	O	O	O	O	O	Same as PD#7
Side Lamp	Laser Module	Laser Module	Laser Module	Laser Module	Laser Module	Same as PD#7
Field Size / SID Display	Color LCD	Color LCD	Color LCD	Color LCD	Color LCD	Same as PD#7
Detector
Name	S4335-W/ S4335-AW	S4343-W/ S4343-AW	S3025-W	S4335-W/ S4335-AW	S4343-W/ S4343-AW	S3025-W	Same as PD#7
Detector Type	Csl
Indirect	Csl
Indirect	Csl
Indirect	Csl
Indirect	Csl
Indirect	Csl
Indirect	Same as PD#7
Detector Area	14"X 17"
(345 mmX 425m m)	17"X 17"
(425 mmX 425m m)	10"X12"
(245 mmX 295m m)	14"X 17"
(345 mmX 425m m)	17"X 17"
(425 mmX 425m m)	10"X12"
(245 mmX 295m m)	Same as PD#7
Number of pixels	2466 X304 0	3036 X304 0	1750 X210 8	2466 X304 0	3036 X304 0	1750 X210 8	Same as PD#7
Pixel Pitch(um)	140	140	140	140	140	140	Same as PD#7
High Contrast Limiting Resolution (LP/mm)	3.57	3.57	3.57	3.57	3.57	3.57	Same as PD#7
Communication	Wired / Wireless	Wired / Wireless	Wired / Wireless	Wired / Wireless	Wired / Wireless	Wired / Wireless	Same as PD#7
Image Post-processing Engine
Noise reduction algorithm	Image Post-processing Engine with an advanced noise reduction algorithm	Image Post-processing Engine with an advanced noise reduction algorithm	Image Post-processing Engine with an advanced noise reduction algorithm				Same as PD#7
	50% dose reduction for chest PA of average adult	50% dose reduction for chest PA of average adult	50% dose reduction for chest PA of average adult				Same as PD #7
Claim of dose reduction	Up to 47.5% dose reduction for abdominal radiographs of adult		-				Different(1)
	Up to 45% dose reduction for pediatric		-				Different(2)

27

Image /page/27/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is inside of a blue, oval shape.

510(k) Premarket Notification - Traditional

| pediatric chest, and
up to 27% for pediatric

skull exams
----------------------------------------------------------------	--	--

No	Differences	Explanation
(1)	Up to 47.5% dose reduction for abdominal radiographs of adult	The claim for dose reduction of abdominal radiographs of adult is added to the proposed devices. The proposed devices with the new IPE employing and advanced noise reduction algorithm are able to reduce x-ray dose up to 47.5% for abdominal radiographs of average adult, compared with radiation doses needed to obtain similar image quality using the old IPE on the same x-ray systems.
(2)	Up to 45% dose reduction for pediatric abdomen, 15.5% for pediatric chest, and up to 27% for pediatric skull exams	The claims for dose reduction of pediatric population are added to the proposed devices. The proposed devices with the new IPE employing and advanced noise reduction algorithm are able to reduce x-ray dose up to 45% for pediatric abdomen, 15.5% for pediatric chest, and up to 27% for pediatric skull exams, compared with radiation doses needed to obtain similar image quality using the old IPE on the same x-ray systems.

B. Safety and EMC

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

The quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom taken at a various exposure condition using GM85. Contrast to Noise Ratio (CNR), Detail Compacted Contrast (DCC) and Modulation Transfer Functions (MTF) of the images were measured and compared. As a result of comparison, CNR was measured highly under the condition of the new IPE in comparison with the old IPE and the other image quality metrics such as DCC and MTF of the new IPE were equivalent to those of the old IPE. The non-clinical data shows that images using the new IPE make it easy to distinguish between background and the object, and is clearer than images using the old IPE. Ant it says that the performance of the new IPE is robustness with regard to the variation of X-ray exposure factors such as kVp values and 0.1 mm Cu filter on/off.

D. Clinical data

i. Abdominal radiograph for adult

28

Image /page/28/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The wordmark is placed on a blue, rounded, oval-shaped background.

510(k) Premarket Notification - Traditional

GC85A as a representative device of the proposed devices was validated with anthropomorphic phantom images and clinical images by three and two professional radiologists respectively. Anthropomorphic phantom images captured at different radiation exposures were scored by the 5-point grading scale in consideration of anatomical regions and physical parameters. Clinical images captured at two different radiation exposures were also scored by the 5-point grading scale for the assessment of overall image quality such as sharpness and visualization for the anatomical regions.

The anthropomorphic phantom image study shows that the new IPE with an advanced noise reduction algorithm retained the quality of images captured at 47.5% reduced exposure in comparison with the old IPE. In detail, we performed a paired t-test comparison between each lower dose image and the reference image; the old IPE maintained the image quality at as low as 0.4 mGy, while the new IPE maintained the image quality at as low as 0.21 mGy. We derived the dose reduction 47.5% by calculating (0.4-0.21)/0.4*100. We confirmed that it was possible to reduce the dose in clinical images as well.

Based on the evaluation of anthropomorphic phantom images, the new IPE enables to reduce the dose of 47.5%.

ii. Pediatric population

GC85A as a representative device of the proposed devices were evaluated using a validated noise simulation tool in pursue of dose optimization with the new IPE relative to the old IPE for chest, abdomen and skull of pediatric populations.

Dose reduction performance was calculated by a statistical method based on a clinical trial. Three experienced pediatric radiologists assessed the series of dose-simulated images to decide the optimal dose for each patient. The optimal dose means the lowest dose at which image quality is still appropriate for diagnosis. On the whole, image processed by new IPE could achieve lower optimal dose than the old IPE. We analyzed the difference between the optimal doses for old IPE and new IPE images.

Based on the evaluation, the performance of the new IPE shows that the images using the new IPE taken at up to 45% reduction for pediatric abdomen. 15.5% for pediatric chest, and up to 27% pediatric skull in radiation dose are substantially equivalent of those using the old IPE without sacrificing diagnostic confidence, although dose reduction rate is various in accordance with protocols such as chest, abdomen and skull and pediatric sub-population.

E. Conclusions

There is no difference between the proposed devices and the predicate devices in technical and physical characteristics.

Differences in the devices do not alter the intended use/indications. The non-clinical and clinical data demonstrate that the proposed devices are as safe, as effective, and performs as well as the legally marketed predicate devices.