GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

K182183 · Samsung Electronics Co., Ltd. · KPR · Dec 7, 2018 · Radiology

Device Facts

Record IDK182183
Device NameGC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
ApplicantSamsung Electronics Co., Ltd.
Product CodeKPR · Radiology
Decision DateDec 7, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1680
Device ClassClass 2
AttributesPediatric

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 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.

Device Story

Digital X-ray imaging systems (stationary and mobile) capture radiographic images of human anatomy. X-rays pass through the patient to a detector, converting radiation into electrical signals. Signals are processed by the S-station (Operation Software) and saved as DICOM files. An Image Post-processing Engine (IPE) performs region-of-interest extraction, tonescale mapping, noise reduction, and texture restoration. The device is operated by qualified doctors or technicians in clinical settings. The IPE's advanced noise reduction algorithm allows for reduced radiation dose (up to 47.5% for adult abdomen; up to 45% for pediatric abdomen, 15.5% for pediatric chest, and 27% for pediatric skull) while maintaining diagnostic image quality. Output is sent to PACS for radiologist review. Dose reduction benefits patients by minimizing radiation exposure while maintaining diagnostic confidence.

Clinical Evidence

Evidence includes non-clinical phantom testing (TOR CDR phantom) and clinical evaluations. Phantom testing measured CNR, DCC, and MTF, showing improved CNR with the new IPE. Clinical validation for adult abdomen used anthropomorphic phantoms and clinical images scored by radiologists on a 5-point scale, confirming 47.5% dose reduction. Pediatric population evaluation used a noise simulation tool and clinical trial data; three pediatric radiologists assessed dose-simulated images to determine optimal diagnostic dose, confirming dose reductions of 45% (abdomen), 15.5% (chest), and 27% (skull).

Technological Characteristics

Stationary and mobile digital X-ray systems. High-frequency generators (up to 82kW). X-ray tubes with Rhenium-Tungsten targets. Indirect CsI or Gd2O2S detectors (140um pixel pitch). Connectivity via wired/wireless DICOM. Software includes S-station OS and IPE with advanced noise reduction algorithm. Standards: ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO 14971.

Indications for Use

Indicated for generating radiographic images of human anatomy, including adult abdominal and pediatric chest, abdomen, and skull exams. Not for mammography. For use by qualified/trained doctors or technicians.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{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) | | |--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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) | <span> <span style="padding-right: 20px;"> <span style="padding-right: 5px;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-right: 5px;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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. | <span> <span style="font-size: 10px;"> <span style="text-decoration: underline;"></span> </span> <span style="font-size: 10px;"> <span style="text-decoration: underline;"></span> </span> </span> | <span> <span style="font-size: 10px;"> <span style="text-decoration: underline;"></span> </span> <span style="font-size: 10px;"> <span style="text-decoration: underline;"></span> </span> </span> <span> </span> <span> <span style="font-size: 10px;"> <span style="text-decoration: underline;"></span> </span> <span style="font-size: 10px;"> <span style="text-decoration: underline;"></span> </span> </span> <span> </span> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block;"> <div style="display:inline-block;"> <div style="display:inline-block;"> <img alt="checkbox" src="checkbox_checked.png" style="width:10px;height:10px;"/> </div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:inline-block;"> <div style="display:inline-block;"> <div style="display:inline-block;"> <img alt="checkbox" src="checkbox.png" style="width:10px;height:10px;"/> </div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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) | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="padding-right: 20px;"> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | 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) | | |-------------------------------------------------------------------------------------------------|----------------------------------------------------------| | <div><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | 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<br>Name | GC70 | GU60A&<br>GU60A-<br>65 | GF50 | GF50A | GR40C<br>W | GM85 | GC85A | | Device<br>Name | GC70 | GU60A&<br>GU60A-<br>65 | GF50 | GF50A | GR40C<br>W | GM85 | GC85A | | Common<br>Name | Digital<br>Diagnos<br>tic X-ray<br>System | Digital<br>Diagnos<br>tic X-ray<br>System | Digital<br>Diagnos<br>tic X-ray<br>System | Digital<br>Diagnos<br>tic X-ray<br>System | Retrofit<br>Kit | Digital<br>Diagnos<br>tic<br>Mobile<br>X-ray<br>System | Digital<br>Diagnos<br>tic X-ray<br>System | | Regulation<br>Name | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Mobile<br>X-ray<br>System | Stationar<br>y X-ray<br>System | | Product<br>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<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.172<br>0 | 21 CFR<br>892.168<br>0 | |------------|------------------------|------------------------|------------------------|------------------------|------------------------|------------------------|------------------------| |------------|------------------------|------------------------|------------------------|------------------------|------------------------|------------------------|------------------------| #### 6. Predicate Devices | | | Predicate Devices | | | | | | | |----------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|------------------------------------|---------------------------|--------------------------------|--| | | #1 | #2 | #3 | #4 | #5 | #6 | #7 | | | Device<br>Name | GC70 | GU60A&<br>GU60A-<br>65 | GF50 | GF50A | GR40C<br>W | GM85 | GC85A | | | Classificati<br>on Name | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Stationar<br>y X-ray<br>System | Solid<br>State X-<br>ray<br>Imager | Mobile<br>X-ray<br>System | Stationar<br>y X-ray<br>System | | | Product<br>Code | KPR | KPR | KPR | KPR | MQB | IZL | KPR | | | Regulation | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.168<br>0 | 21 CFR<br>892.172<br>0 | 21 CFR<br>892.168<br>0 | | | 510(K)# | K180543 | K180543 | K180543 | K180543 | K181631 | K181626 | K181629 | | | 510(K)<br>Decision<br>Date | May 24,<br>2018 | May 24,<br>2018 | May 24,<br>2018 | May 24,<br>2018 | July 20,<br>2018 | July 20,<br>2018 | July 20,<br>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 {12}------------------------------------------------ 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. - 9. 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<br>40-150kV | Tube Voltage<br>40-150kV | Same as PD#1 | | | Tube Current<br>10-1000mA | Tube Current<br>10-1000mA | Same as PD#1 | | | Exposure Time<br>1msec-10sec | Exposure Time<br>1msec-10sec | Same as PD#1 | | AEC (Automatic Exposure Control) | Yes | Yes | Same as PD#1 | #### A. Compared with Predicate Devices {13}------------------------------------------------ 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<br>(Anatomically<br>Programmed<br>Radiography) | | | Yes | | | Yes | | | Same as PD#1 | |----------------------------------------------------|-----------------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|--------------|--------------| | 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.<br>Power | Large focus | 100kW | 75kW | 100kW | 75kW | Same as PD#1 | | | | | | Small focus | 40kW | 27kW | 40kW | 27kW | Same as PD#1 | | | | | Max.<br>mA | Large focus | 1000mA | 1000mA | 1000mA | 1000mA | Same as PD#1 | | | | | | Small focus | 500mA | 400mA | 500mA | 400mA | Same as PD#1 | | | | | | Anode target<br>material | Rhenium-<br>Tungsten | Rhenium-<br>Tungsten | Rhenium-<br>Tungsten | Rhenium-<br>Tungsten | Same as PD#1 | | | | | Collimator | | | | | | | | | | | | Name | SDR-OGCL83U | SDR-OGCL83U | Same as PD#1 | | | | | | | | Overall<br>Size(mm) | H212 X W306<br>X D179 | H212 X W306<br>X D179 | Same as PD#1 | | | | | | | | Beam Limiting<br>Blade<br>Moving Method | | Motorized<br>/Manual | Motorized<br>/Manual | Same as PD#1 | | | | | | | Manual<br>Operation<br>Method | | Volume | Volume | Same as PD#1 | | | | | | Collimator<br>Rotation | | ±45 | ±45 | Same as PD#1 | | | | | | | | Beam Light<br>Source | LED | LED | Same as PD#1 | | | | | | | | Light Field<br>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<br>Display | Color LCD | Color LCD | Same as PD#1 | | | | | | | Detector | | | | | | | | | | | | Name | S433<br>5-W | S434<br>3-W | S302<br>5-W | S433<br>5-W | S434<br>3-W | S302<br>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<br>7"<br>(345 mmX<br>425m m) | 17"X1<br>7"<br>(425 mmX<br>425m m) | 10"X1<br>2"<br>(245 mmX<br>295m m) | 14"X1<br>7"<br>(345 mmX<br>425m m) | 17"X1<br>7"<br>(425 mmX<br>425m m) | 10"X1<br>2"<br>(245 mmX<br>295m m) | Same as PD#1 | | | | Number of<br>pixels | 2466<br>X3040 | 3036<br>X3040 | 1750<br>X2108 | 2466<br>X3040 | 3036<br>X3040 | 1750<br>X2108 | Same as PD#1 | | {14}------------------------------------------------ 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<br>Limiting<br>Resolution<br>(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#1 | | Communication | Wired /<br>Wirel<br>ess | Wired /<br>Wirel<br>ess | Wired /<br>Wirel<br>ess | Wired /<br>Wirel<br>ess | Wired /<br>Wirel<br>ess | Wired /<br>Wirel<br>ess | Same as PD#1 | | Image Post-processing Engine | | | | | | | | | Noise reduction<br>algorithm | Image Post-<br>processing Engine<br>with an advanced<br>noise reduction<br>algorithm | | | | | | Same as PD#1 | | Claim of dose<br>reduction | 50% dose reduction<br>for chest PA of<br>average adult | | | | | | Same as PD #1 | | | Up to 47.5% dose<br>reduction for<br>abdominal<br>radiographs of adult | | | | | | Different(1) | | | Up to 45% dose<br>reduction for pediatric<br>abdomen, 15.5% for<br>pediatric chest, and<br>up to 27% for pediatric<br>skull exams | | | | | | Different(2) | | Specification | Proposed Device #2 | | Predicate Device #2<br>(PD #2) | | Discussion | | | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|--------------------|-------------------|---------------| | | GU60A | GU60A-65 | GU60A | GU60A-65 | | | | | Device Name | GU60A & GU60A-65 | | GU60A & GU60A-65 | | | | | | Manufacturer | SAMSUNG<br>ELECTRONICS Co.,<br>Ltd. | | SAMSUNG<br>ELECTRONICS Co.,<br>Ltd. | | | | | | 510(k) Number | None | | K180543 | | | | | | Intended Use | The GU60A &<br>GU60A-65 Digital X-<br>ray Imaging Systems<br>are intended for use in<br>generating<br>radiographic images<br>of human anatomy by<br>a qualified/trained<br>doctor or technician.<br>This device is not<br>intended for<br>mammographic<br>applications. | | The GU60A &<br>GU60A-65 Digital X-<br>ray Imaging Systems<br>are intended for use in<br>generating<br>radiographic images<br>of human anatomy by<br>a qualified/trained<br>doctor or technician.<br>This device is not<br>intended for<br>mammographic<br>applications. | | Same as PD#2 | | | | High Voltage Generator<br>Type | High Frequency | | High Frequency | | Same as PD#2 | | | | | Max. Power | 50kW/68kW | 65kW | 50kW/68kW | 65kW | Same as PD#2 | | | | Tube<br>Voltage | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | Same as PD#2 | | | Output<br>RANGE | Tube<br>Current | 10 - 630mA/<br>10 - 800mA | 10 - 800mA | 10 - 630mA/<br>10 - 800mA | 10 - 800mA | Same as PD#2 | | | | Exposure<br>Time | 1msec-<br>6.3sec/<br>1msec-<br>10sec | 1msec-<br>6.3sec | 1msec-<br>6.3sec/<br>1msec-<br>10sec | 1msec-<br>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.<br>Power | Large<br>focus | 75kW | | 75kW | | Same as PD#2 | | | r | Small<br>focus | 27kW | | 27kW | | Same as PD#2 | | | Max.<br>mA | Large<br>focus | 1000mA | | 1000mA | | Same as PD#2 | | | | Small<br>focus | 400mA | | 400mA | | Same as PD#2 | | | Anode target<br>material | | Rhenium-Tungsten | | Rhenium-Tungsten | | Same as PD#2 | | | Collimator | | | | | | | | | | Name | SDR-OGCL82U | | SDR-OGCL82U | | Same as PD#2 | | | | Overall<br>Size(mm) | H212 X W306<br>X D179 | | H212 X W306<br>X D179 | | Same as PD#2 | | | | Beam Limiting<br>Blade<br>Moving Method | Motorized<br>/Manual | | Motorized<br>/Manual | | Same as PD#2 | | | | Manual<br>Operation<br>Method | Volume | | Volume | | Same as PD#2 | | | | Collimator<br>Rotation | ±45 | | ±45 | | Same as PD#2 | | | | Beam Light<br>Source | LED | | LED | | Same as PD#2 | | | | Light Field<br>Indicator Timer | O | | O | | Same as PD#2 | | | | Side Lamp | Laser Module | | Laser Module | | Same as PD#2 | | | | Field Size / SID<br>Display | Color LCD | | Color LCD | | Same as PD#2 | | | Detector | | | | | | | | | | Name | S433<br>5-W | S434<br>3-W | S302<br>5-W | S433<br>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…
Innolitics
510(k) Summary
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