GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A by Samsung Electronics Co., LTD.

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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and a study proving the device meets those criteria, specifically concerning dose reduction capabilities of the Image Post-processing Engine (IPE) with an advanced noise reduction algorithm in Samsung Digital X-ray Systems (GC70, GU60A, GU60A-65, GF50, GF50A, GR40CW, GM85, and GC85A).

Here is the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion is the ability of the new IPE to reduce X-ray dose while maintaining image quality comparable to the old IPE for diagnostic confidence. The specific dose reduction percentages are the performance metrics.

Acceptance Criterion	Reported Device Performance
Dose Reduction for Adult Abdominal Radiographs	Up to 47.5% dose reduction for abdominal radiographs of adult, compared to the old IPE while achieving similar image quality.
Dose Reduction for Pediatric Abdomen	Up to 45% dose reduction for pediatric abdomen, compared to the old IPE while achieving similar image quality.
Dose Reduction for Pediatric Chest	15.5% dose reduction for pediatric chest, compared to the old IPE while achieving similar image quality.
Dose Reduction for Pediatric Skull	Up to 27% dose reduction for pediatric skull, compared to the old IPE while achieving similar image quality.

2. Sample Size Used for the Test Set and Data Provenance

Adult Abdominal Radiograph Test Set:
- Anatomical phantom images: Number of images not specified, but taken at "various exposure condition." The study states, "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."
- Clinical images: Number of images not specified, but used to "confirm that it was possible to reduce the dose in clinical images as well."
- Provenance: Not explicitly stated, but the submission is from Samsung Electronics Co., LTD. Republic of Korea. The clinical testing was conducted at "one medical site."
- Retrospective or Prospective: Not specified.
Pediatric Population Test Set (Chest, Abdomen, Skull):
- Number of images: "Series of dose-simulated images" for each body part.
- Number of patients: Not specified explicitly, but mentioned as "each patient."
- Provenance: Not explicitly stated, but the submission is from Samsung Electronics Co., LTD. Republic of Korea. The clinical testing was conducted at "one medical site."
- Retrospective or Prospective: Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Adult Abdominal Radiograph Test Set:
- Anatomical phantom images were reviewed by three professional radiologists.
- Clinical images were reviewed by two professional radiologists.
- Qualifications: "Professional radiologists" (no further details on experience given).
Pediatric Population Test Set:
- Three experienced pediatric radiologists.
- Qualifications: "Experienced pediatric radiologists" (no further details on experience given).

4. Adjudication Method for the Test Set

The adjudication method is not explicitly detailed. However, for both adult and pediatric studies, images were "scored by the 5-point grading scale" for assessment of image quality. This implies individual scoring, and for the pediatric study, "Three experienced pediatric radiologists assessed the series of dose-simulated images to decide the optimal dose for each patient." The decision for the "optimal dose" for pediatric cases suggests a consensus or agreement among these experts, but the exact method (e.g., majority vote, discussion to reach consensus) is not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done to evaluate human readers' improvement with AI vs. without AI assistance. The study focused on the device's standalone performance in enabling dose reduction while maintaining image quality as assessed by human readers. The new IPE is a component within the imaging system, not an AI assistance tool for human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies evaluated the standalone performance of the new IPE algorithm in terms of enabling dose reduction while maintaining image quality. The performance was assessed by comparing images processed by the new IPE at reduced doses against images from the old IPE or a reference, with human experts providing the assessment of image quality and diagnostic appropriateness.

7. The Type of Ground Truth Used

The ground truth for both adult and pediatric studies was expert consensus/assessment of image quality and diagnostic appropriateness.

For adult abdominal radiographs: Expert radiologists scored images based on a 5-point grading scale, considering anatomical regions, physical parameters, sharpness, and visualization.
For pediatric populations: Experienced pediatric radiologists assessed dose-simulated images to determine the "optimal dose" at which image quality remained appropriate for diagnosis.

Additionally, phantom studies (TOR CDR radiography phantom and anthropomorphic phantom) were used to quantitatively assess image quality metrics like Contrast to Noise Ratio (CNR), Detail Compacted Contrast (DCC), and Modulation Transfer Functions (MTF).

8. The Sample Size for the Training Set

The document does not provide information about the training set size for the Image Post-processing Engine (IPE) algorithm. It focuses on the validation of the algorithm's dose reduction capabilities.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established for the IPE algorithm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K182183

Device Name

GC85A

Indications for Use (Describe)

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

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Indications for Use

510(k) Number (if known) K182183

Device Name GC70

Indications for Use (Describe)

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.

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Indications for Use

510(k) Number (if known) K182183

Device Name GU60A, GU60A-65

Indications for Use (Describe)

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.

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.

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Indications for Use

510(k) Number (if known) K182183

Device Name GF50

Indications for Use (Describe)


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

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

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

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.

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)

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Indications for Use

510(k) Number (if known) K182183

Device Name GF50A

Indications for Use (Describe)

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.

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."

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Indications for Use

510(k) Number (if known)

K182183

Device Name GR40CW

Indications for Use (Describe)

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.

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.

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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.

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.

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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
TradeName	GC70	GU60A&GU60A-65	GF50	GF50A	GR40CW	GM85	GC85A
DeviceName	GC70	GU60A&GU60A-65	GF50	GF50A	GR40CW	GM85	GC85A
CommonName	DigitalDiagnostic X-raySystem	DigitalDiagnostic X-raySystem	DigitalDiagnostic X-raySystem	DigitalDiagnostic X-raySystem	RetrofitKit	DigitalDiagnosticMobileX-raySystem	DigitalDiagnostic X-raySystem
RegulationName	Stationary X-raySystem	Stationary X-raySystem	Stationary X-raySystem	Stationary X-raySystem	Stationary X-raySystem	MobileX-raySystem	Stationary X-raySystem
ProductCode	KPR	KPR	KPR	KPR	MQB	IZL	KPR

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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 CFR892.1680	21 CFR892.1680	21 CFR892.1680	21 CFR892.1680	21 CFR892.1680	21 CFR892.1720	21 CFR892.1680
------------	------------------------	------------------------	------------------------	------------------------	------------------------	------------------------	------------------------

6. Predicate Devices

		Predicate Devices
	#1	#2	#3	#4	#5	#6	#7
DeviceName	GC70	GU60A&GU60A-65	GF50	GF50A	GR40CW	GM85	GC85A
Classification Name	Stationary X-raySystem	Stationary X-raySystem	Stationary X-raySystem	Stationary X-raySystem	SolidState X-rayImager	MobileX-raySystem	Stationary X-raySystem
ProductCode	KPR	KPR	KPR	KPR	MQB	IZL	KPR
Regulation	21 CFR892.1680	21 CFR892.1680	21 CFR892.1680	21 CFR892.1680	21 CFR892.1680	21 CFR892.1720	21 CFR892.1680
510(K)#	K180543	K180543	K180543	K180543	K181631	K181626	K181629
510(K)DecisionDate	May 24,2018	May 24,2018	May 24,2018	May 24,2018	July 20,2018	July 20,2018	July 20,2018

7. Device Description

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).

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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

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 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.

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 Voltage40-150kV	Tube Voltage40-150kV	Same as PD#1
	Tube Current10-1000mA	Tube Current10-1000mA	Same as PD#1
	Exposure Time1msec-10sec	Exposure Time1msec-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(AnatomicallyProgrammedRadiography)			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 targetmaterial	Rhenium-Tungsten	Rhenium-Tungsten	Rhenium-Tungsten	Rhenium-Tungsten	Same as PD#1
Collimator
	Name	SDR-OGCL83U	SDR-OGCL83U	Same as PD#1
	OverallSize(mm)	H212 X W306X D179	H212 X W306X D179	Same as PD#1
	Beam LimitingBladeMoving Method		Motorized/Manual	Motorized/Manual	Same as PD#1
	ManualOperationMethod		Volume	Volume	Same as PD#1
CollimatorRotation		±45	±45	Same as PD#1
	Beam LightSource	LED	LED	Same as PD#1
	Light FieldIndicator 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 / SIDDisplay	Color LCD	Color LCD	Same as PD#1
Detector
	Name	S4335-W	S4343-W	S3025-W	S4335-W	S4343-W	S3025-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"X17"(345 mmX425m m)	17"X17"(425 mmX425m m)	10"X12"(245 mmX295m m)	14"X17"(345 mmX425m m)	17"X17"(425 mmX425m m)	10"X12"(245 mmX295m m)	Same as PD#1
	Number ofpixels	2466X3040	3036X3040	1750X2108	2466X3040	3036X3040	1750X2108	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 ContrastLimitingResolution(LP/mm)	3.57	3.57	3.57	3.57	3.57	3.57	Same as PD#1
Communication	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Same as PD#1
Image Post-processing Engine
Noise reductionalgorithm	Image Post-processing Enginewith an advancednoise reductionalgorithm						Same as PD#1
Claim of dosereduction	50% dose reductionfor chest PA ofaverage adult						Same as PD #1
	Up to 47.5% dosereduction forabdominalradiographs of adult						Different(1)
	Up to 45% dosereduction for pediatricabdomen, 15.5% forpediatric chest, andup to 27% for pediatricskull 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	SAMSUNGELECTRONICS Co.,Ltd.		SAMSUNGELECTRONICS Co.,Ltd.
510(k) Number	None		K180543
Intended Use	The GU60A &GU60A-65 Digital X-ray Imaging Systemsare intended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications.		The GU60A &GU60A-65 Digital X-ray Imaging Systemsare intended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications.		Same as PD#2
High Voltage GeneratorType	High Frequency		High Frequency		Same as PD#2
	Max. Power	50kW/68kW	65kW	50kW/68kW	65kW	Same as PD#2
	TubeVoltage	40 to 150kVp	40 to 150kVp	40 to 150kVp	40 to 150kVp	Same as PD#2
OutputRANGE	TubeCurrent	10 - 630mA/10 - 800mA	10 - 800mA	10 - 630mA/10 - 800mA	10 - 800mA	Same as PD#2
	ExposureTime	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	Largefocus	75kW		75kW		Same as PD#2
r	Smallfocus	27kW		27kW		Same as PD#2
Max.mA	Largefocus	1000mA		1000mA		Same as PD#2
	Smallfocus	400mA		400mA		Same as PD#2
Anode targetmaterial		Rhenium-Tungsten		Rhenium-Tungsten		Same as PD#2
Collimator
	Name	SDR-OGCL82U		SDR-OGCL82U		Same as PD#2
	OverallSize(mm)	H212 X W306X D179		H212 X W306X D179		Same as PD#2
	Beam LimitingBladeMoving Method	Motorized/Manual		Motorized/Manual		Same as PD#2
	ManualOperationMethod	Volume		Volume		Same as PD#2
	CollimatorRotation	±45		±45		Same as PD#2
	Beam LightSource	LED		LED		Same as PD#2
	Light FieldIndicator Timer	O		O		Same as PD#2
	Side Lamp	Laser Module		Laser Module		Same as PD#2
	Field Size / SIDDisplay	Color LCD		Color LCD		Same as PD#2
Detector
	Name	S4335-W	S4343-W	S3025-W	S4335-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	SAMSUNGELECTRONICS Co.,Ltd.	SAMSUNGELECTRONICS Co.,Ltd.
510(k) Number	None	K180543
Intended Use	The GF50 Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/trained	The GF50 Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/trained	Same as PD#3
doctor or technician.This device is notintended formammographicapplications.			doctor or technician.This device is notintended formammographicapplications.
High Voltage Generator	Type	High Frequency	High Frequency	Same as PD#3
	Max. Power	52kW	52kW	Same as PD#3
OutputRANGE	TubeVoltage	40-150kV	40-150kV	Same as PD#3
	TubeCurrent	10-640mA	10-640mA	Same as PD#3
	ExposureTime	1msec-10sec	1msec-10sec	Same as PD#3
	AEC(AutomaticExposureControl)	Yes	Yes	Same as PD#3
	APR(AnatomicallyProgrammedRadiography)	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.Power	Largefocus	75kW	75kW	Same as PD#3
	Smallfocus	27kW	27kW	Same as PD#3
Max.mA	Largefocus	1000mA	1000mA	Same as PD#3
	Smallfocus	400mA	400mA	Same as PD#3
	Anode targetmaterial	Rhenium-Tungsten	Rhenium-Tungsten	Same as PD#3
Collimator
	Name	SDR-OGCL50D	SDR-OGCL50D	Same as PD#3
	OverallSize(mm)	H185 X W213X D180	H185 X W213X D180	Same as PD#3
	Beam LimitingBladeMoving Method	Manual	Manual	Same as PD#3
	ManualOperationMethod	Volume	Volume	Same as PD#3
	CollimatorRotation	±45	±45	Same as PD#3
Light FieldIndicator 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 / SIDDisplay	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 ofpixels	2466X3040	2466X3040	Same as PD#3
Pixel Pitch(um)	140	140	Same as PD#3
High ContrastLimitingResolution(LP/mm)	3.5	3.5	Same as PD#3
Communication	Wired / Wireless	Wired / Wireless	Same as PD#3
Image Post-processing Engine
Noise reductionalgorithm	Image Post-processing Enginewith an advanced	Image Post-processing Enginewith an advanced	Same as PD#3
	noise reductionalgorithm	noise reductionalgorithm
	50% dose reductionfor chest PA ofaverage adult	50% dose reductionfor chest PA ofaverage adult	Same as PD #3
Claim of dose	Up to 47.5% dosereduction forabdominalradiographs of adult	-	Different(1)
reduction	Up to 45% dosereduction for pediatricabdomen, 15.5% forpediatric chest, andup to 27% for pediatricskull 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	SAMSUNGELECTRONICS Co.,Ltd.	SAMSUNGELECTRONICS Co.,Ltd.
510(k) Number	None	K180543
Intended Use		The GF50A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications.	The GF50A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications.	Same as PD#4
High	Voltage Generator
	Type	High Frequency	High Frequency	Same as PD#4
	Max. Power	40kW	40kW	Same as PD#4
	TubeVoltage	40-125kV	40-125kV	Same as PD#4
OutputRANGE	TubeCurrent	10-500mA	10-500mA	Same as PD#4
	ExposureTime	1msec-10sec	1msec-10sec	Same as PD#4
	AEC(AutomaticExposureControl)	Yes	Yes	Same as PD#4
APR(AnatomicallyProgrammedRadiography)		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.Power	Largefocus	75kW	75kW	Same as PD#4
	Smallfocus	27kW	27kW	Same as PD#4
Max.mA	Largefocus	1000mA	1000mA	Same as PD#4
	Smallfocus	400mA	400mA	Same as PD#4
	Anode targetmaterial	Rhenium-Tungsten	Rhenium-Tungsten	Same as PD#4
Collimator
	Name	SDR-OGCL50D	SDR-OGCL50D	Same as PD#4
	OverallSize(mm)	H185 X W213X D180	H185 X W213X D180	Same as PD#4
Beam LimitingBladeMoving Method		Manual	Manual	Same as PD#4
ManualOperationMethod	Volume	Volume	Same as PD#4
CollimatorRotation	$\pm$ 90	$\pm$ 90	Same as PD#4
Beam LightSource	Halogen Lamp	Halogen Lamp	Same as PD#4
Light FieldIndicator Timer	O	O	Same as PD#4
Side Lamp	Laser Module	Laser Module	Same as PD#4
Field Size / SIDDisplay	Color LCD	Color LCD	Same as PD#4
Detector
Name	S4335-W	S4335-W	Same as PD#4
Detector Type	CslIndirect	CslIndirect	Same as PD#4
Detector Area	14"X17"(345mmX425mm)	14"X17"(345mmX425mm)	Same as PD#4
Number ofpixels	2466X3040	2466X3040	Same as PD#4
Pixel Pitch(um)	140	140	Same as PD#4
High ContrastLimitingResolution(LP/mm)	3.5	3.5	Same as PD#4
Communication	Wired / Wireless	Wired / Wireless	Same as PD#4
Image Post-processing Engine
Noise reductionalgorithm	Image Post-processing Enginewith an advancednoise reductionalgorithm	Image Post-processing Enginewith an advancednoise reductionalgorithm	Same as PD#4
Claim of dosereduction	50% dose reductionfor chest PA ofaverage adult	50% dose reductionfor chest PA ofaverage adult	Same as PD #4
	Up to 47.5% dosereduction forabdominalradiographs of adult	-	Different(1)
	Up to 45% dosereduction for pediatricabdomen, 15.5% forpediatric chest, andup to 27% for pediatricskull 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	SAMSUNGELECTRONICS Co.,Ltd.		SAMSUNGELECTRONICS Co., Ltd.
510(k) Number	None			K181631
Intended Use	The GR40CW DigitalX-ray Imaging Systemis intended for use ingeneral projectionradiographicapplications whereverconventional screen-film systems or CRsystems may be used.This device is notintended formammographicapplications.		The GR40CW DigitalX-ray Imaging Systemis intended for use ingeneral projectionradiographicapplications whereverconventional screen-film systems or CRsystems may beused. This device isnot intended formammographicapplications.				Same as PD#5
Detector
Name	S4335-W/S4335-AW	S4335-WV/S4335-AWV	S4343-W/S4343-AW	S3025-W	S4335-W/S4335-AW	S4335-WV/S4335-AWV	S4343-W/S4343-AW	S3025-W	Same as PD#5
Detector Type	CsI	Gd₂O₂S	CsI	CsI	CsI	Gd₂O₂S	CsI	CsI	Same as PD#5
	Indirect	Indirect	Indirect	Indirect	Indirect	Indirect	Indirect	Indirect	Same as PD#5
Detector Area	14"X17"(345mmX425mm)	14"X17"(345mmX425mm	17"X17"(425mmX425mm	10"X12"(245mmX295mm	14"X17"(345mmX425mm	14"X17"(345mmX425mm	17"X17"(425mmX425mm	10"X12"(245mmX295mm	Same as PD#5
Number ofpixels	2466X3040	2466X3040	3036X3040	1750X2108	2466X3040	2466X3040	3036X3040	1750X2108	Same as PD#5
Pixel Pitch(um)	140	140	140	140	140	140	140	140	Same as PD#5
High ContrastLimitingResolution(LP/mm)	3.57	3.5	3.57	3.57	3.57	3.5	3.57	3.57	Same as PD#5
Communication	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	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 reductionalgorithm	Image Post-processing Enginewith an advancednoise reductionalgorithm	Image Post-processing Enginewith an advancednoise reductionalgorithm	Same as PD#5
Claim of dosereduction	50% dose reductionfor chest PA ofaverage adult	50% dose reductionfor chest PA ofaverage adult	Same as PD #5
	Up to 47.5% dosereduction forabdominalradiographs of adult	-	Different(1)
	Up to 45% dosereduction for pediatricabdomen, 15.5% forpediatric chest, and upto 27% for pediatricskull exams	-	Different(2)

Specification	Proposed Device #6	Predicate Device #6(PD #6)	Discussion
Device Name	GM85	GM85
Manufacturer	SAMSUNGELECTRONICS Co.,Ltd.	SAMSUNGELECTRONICS Co.,Ltd.
510(k) Number	None	K181626
Intended Use	The GM85 DigitalMobile X-ray imagingSystem is intended foruse in generatingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications.	The GM85 DigitalMobile X-ray imagingSystem is intended foruse in generatingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications.	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
TubeVoltage	40 to 150kVp	40 to 150kVp	Same as PD#6
OutputRANGE	TubeCurrent	10 - 500mA	10 - 500mA	Same as PD#6
	ExposureTime	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.

ExposureControl)
APR(AnatomicallyProgrammedRadiography)		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	Largefocus	46kW	45kW	46kW	45kW	Same as PD#6
r	Smallfocus	20kW	19kW	20kW	19kW	Same as PD#6
Max.	Largefocus	600mA	600mA	600mA	600mA	Same as PD#6
mA	Smallfocus	300mA	260mA	300mA	260mA	Same as PD#6
	Anode targetmaterial	Rhenium-Tungsten	Rhenium-Tungsten	Rhenium-Tungsten	Rhenium-Tungsten	Same as PD#6
	Collimator
	Name	SDR-OGCL40U	SDR-OGCL41U	SDR-OGCL40U	SDR-OGCL41U	Same as PD#6
	OverallSize(mm)	H212 XW306X D179	H222 XW271X D140	H212 XW306X D179	H222 XW271X D140	Same as PD#6
	Beam LimitingBladeMoving Method	Motorized/Manual	Manual	Motorized/Manual	Manual	Same as PD#6
	ManualOperationMethod	Volume	Volume	Volume	Volume	Same as PD#6
	CollimatorRotation	+90/-180	+90/-90	+90/-180	+90/-90	Same as PD#6
	Beam LightSource	LED	LED	LED	LED	Same as PD#6
	Light FieldIndicator Timer	O	O	O	O	Same as PD#6
		O	O	O	O	Same as PD#6
	Side Lamp	LaserModule	LaserModule	LaserModule	LaserModule	Same as PD#6
	Field Size / SIDDisplay	ColorLCD	ScaleMark	ColorLCD	ScaleMark	Same as PD#6
	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#6
		Csl	Csl	Csl	Csl	Csl	Csl	Same as PD#6
	Detector Type	Indirect	Indirect	Indirect	Indirect	Indirect	Indirect	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"X17"(345mmX425mm)	17"X17"(425mmX425mm)	10"X12"(245mmX295mm)	14"X17"(345mmX425mm)	17"X17"(425mmX425mm)	10"X12"(245mmX295mm)
Detector Area	2466X3040	3036X3040	1750X2108	2466X3040	3036X3040	1750X2108	Same as PD#6
Number ofpixels							Same as PD#6
Pixel Pitch(um)	140	140	140	140	140	140	Same as PD#6
High ContrastLimitingResolution(LP/mm)	3.57	3.57	3.57	3.57	3.57	3.57	Same as PD#6
Communication	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Wired /Wireless	Same as PD#6
Image Post-processing Engine
Noise reductionalgorithm		Image Post-processing Enginewith an advancednoise reductionalgorithm			Image Post-processing Enginewith an advancednoise reductionalgorithm		Same as PD#6
		50% dose reductionfor chest PA ofaverage adult			50% dose reductionfor chest PA ofaverage adult		Same as PD #6
Claim of dosereduction		Up to 47.5% dosereduction forabdominalradiographs of adult	-				Different(1)
		Up to 45% dosereduction for pediatricabdomen, 15.5% forpediatric chest, andup to 27% for pediatricskull exams	-				Different(2)

Specification	Proposed Device #7	Predicate Device #7(PD #7)	Discussion
Device Name	GC85A	GC85A
Manufacturer	SAMSUNGELECTRONICS Co.,Ltd.	SAMSUNGELECTRONICS Co.,Ltd.
510(k) Number	None	K181629
Intended Use	The GM85 DigitalMobile X-ray imagingSystem is intended foruse in generatingradiographic imagesof human anatomy bya qualified/trained	The GC85A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya 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 notintended formammographicapplications.		doctor or technician.This device is notintended formammographicapplications.		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
TubeVoltage		40-150kV	v40-150kV	40-150kV	40-150kV	40-150kV	v40-150kV	40-150kV	40-150kV	Same as PD#7
OutputRANGE	TubeCurrent	10-1000mA	10-640mA	10-1000mA	10-630mA	10-1000mA	10-640mA	10-1000mA	10-630mA	Same as PD#7
	ExposureTime	1msес-10sec	1msес-10sec	1msес-10sec	1msес-10sec	1msес-10sec	1msес-10sec	1msес-10sec	1msес-10sec	Same as PD#7
	AEC(AutomaticExposureControl)		Yes	Yes	Yes	Yes	Yes	Yes	Yes	Same as PD#7
	APR(AnatomicallyProgrammedRadiography)		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	Largefocus	100kW		75kW		100kW		75kW		Same as PD#7
	Smallfocus	40kW		27kW		40kW		27kW		Same as PD#7
Max.mA	Largefocus	1000mA		1000mA		1000mA		1000mA		Same as PD#7
	Smallfocus	500mA		400mA		500mA		400mA		Same as PD#7
	Anode targetmaterial	Rhenium-Tungsten		Rhenium-Tungsten		Rhenium-Tungsten		Rhenium-Tungsten		Same as PD#7
Collimator
	Name	SDR-OGCL80U		SDR-OGCL83U		SDR-OGCL80U		SDR-OGCL83U		Same as PD#7
OverallSize(mm)		H212 XW300X D179		H212 XW306X D179		H212 XW300X D179		H212 XW306X D179		Same as PD#7
Beam LimitingBladeMoving Method		Motorized/Manual		Motorized/Manual		Motorized/Manual		Motorized/Manual		Same as PD#7
ManualOperationMethod		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	CslIndirect	CslIndirect	CslIndirect	CslIndirect	CslIndirect	CslIndirect	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)

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510(k) Premarket Notification - Traditional

pediatric chest, andup to 27% for pediatricskull exams
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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

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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.

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.