Who is the manufacturer of GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

Samsung Electronics Co., Ltd. filed the 510(k) submission for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (K180543).

What is the FDA product code for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

GC70 (K163115); GU60A&GU60A-65 (K173828); GF50 (K140326); GF50A (K151419); GR40CW (K153401); GM85 (K171119); GC85A (K172229).

Who can help prepare an FDA 510(k) submission like GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

K180543 · Samsung Electronics Co., Ltd. · KPR · May 24, 2018 · Radiology

Device Facts

Record ID	K180543
Device Name	GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
Applicant	Samsung Electronics Co., Ltd.
Product Code	KPR · Radiology
Decision Date	May 24, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2

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. 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 Story

Digital X-ray imaging systems (GC70, GU60A/GU60A-65, GF50, GF50A, GR40CW, GM85) capture human anatomy images via X-ray transmission to a detector. X-rays convert to electrical signals, processed by the S-station (Operation Software) into DICOM files. An Image Post-processing Engine (IPE) performs region-of-interest extraction, tonescale mapping, noise reduction, and texture restoration. Used in clinical settings by physicians or technicians. IPE enables 50% dose reduction for adult chest PA radiography compared to conventional algorithms. Output sent to PACS for clinical reading; aids diagnostic decision-making. Benefits include reduced patient radiation exposure while maintaining image quality.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing using anthropomorphic and radiographic phantoms (TOR CDR, TO20). Metrics included Modulation Transfer Function (MTF), Contrast to Noise Ratio (CNR), and visibility. Results demonstrated equivalent image quality and 50% dose reduction potential for adult chest PA radiography compared to conventional processing.

Technological Characteristics

Stationary and mobile digital X-ray systems. Components: High-frequency generator, Rhenium-Tungsten anode X-ray tube, motorized/manual collimator with LED/laser, indirect Csl detectors (various sizes, 140um pixel pitch). Connectivity: DICOM standard. Software: S-station OS with IPE (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, 21 CFR 1020.30/31.

Indications for Use

Indicated for generating radiographic images of human anatomy in general projection radiography. Not intended for mammographic applications. 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

GC70 (K163115)
GU60A&GU60A-65 (K173828)
GF50 (K140326)
GF50A (K151419)
GR40CW (K153401)
GM85 (K171119)
GC85A (K172229)

Related Devices

K182183 — GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A · Samsung Electronics Co., Ltd. · Dec 7, 2018
K172229 — GC85A · Samsung Electronics Co., Ltd. · Nov 22, 2017
K171138 — Nexus DR Digital X-ray Imaging System · Varex Imaging Corporation · May 17, 2017
K182647 — GC70 · Samsung Electronics Co., Ltd. · Oct 24, 2018
K181629 — GC85A · Samsung Electronics Co., Ltd. · Jul 20, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ May 24, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. SAMSUNG ELECTRONICS CO.,LTD. % Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si. Gyeonggi-do 16677 REPUBLIC OF KOREA ### Re: K180543 Trade/Device Name: GC70. GU60A&GU60A-65. GF50. GF50A. GR40CW. and GM85 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 4, 2018 Received: May 7, 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jo Delfino for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180543 Device Name GC70 Indications for Use (Describe) The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff "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." PRAStaff@fda.hhs.gov Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180543 Device Name GU60A, GU60A-65 Indications for Use (Describe) The GU60A & GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | Type of Use ( Select one or both, as applicable ) | |----------------------------------------------------------| |----------------------------------------------------------| | | ☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) | |--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| --- CONTINUE ON A SEPARATE PAGE IF NEEDED. --- This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180543 Device Name GF50 Indications for Use (Describe) The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services 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) {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180543 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. > Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Type of Use (Select one or both, as applicable) {6}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180543 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) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> \[X] Prescription Use (Part 21 CFR 801 Subpart D) \[] 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 and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {7}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180543 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> ☒Prescription Use (Part 21 CFR 801 Subpart D) ☐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. {8}------------------------------------------------ Image /page/8/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly upwards from left to 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: February 28, 2018 ### 2. Submitter - Company Name: SAMSUNG ELECTRONICS Co., Ltd. A. - B. Address: 145, Pangyoyeok-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13530, Republic of Korea ### 3. Primary Contact Persons - A. Name: Jaesang NOH & Chulsin KIM - B. Title: Regulatory Affairs Senior Professional - C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437 - FAX Number: +82-31-200-6401 D. E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com ### 4. Secondary Contact Person - Name: Genci Omari A. - 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 | | Proposed Devices | | | | | | |-------------------------|-------------------------------------------|----------------------------------------|-------------------------------------------|-------------------------------------------|------------------------------------|-----------------------------------------------------| | | #1 | #2 | #3 | #4 | #5 | #6 | | Trade Name | GC70 | GU60A&GU60 A-65 | GF50 | GF50A | GR40C W | GM85 | | Device Name | GC70 | GU60A&GU60 A-65 | GF50 | GF50A | GR40C W | GM85 | | Common Name | Digital Diagnosti c X-ray System | Digital Diagnostic X- ray System | Digital Diagnosti c X-ray System | Digital Diagnosti c X-ray System | Retrofit Kit | Digital Diagnosti c Mobile X-ray System | | Classificatio n Name | Stationary X-ray System | Stationary X- ray System | Stationary X-ray System | Stationary X-ray System | Solid State X- ray Imager | Mobile X- ray System | | Product Code | KPR | KPR | KPR | KPR | MQB | IZL | | Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.168 | 21 CFR 892.1720 | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo is white text on a blue background. The text is in all capital letters and is slightly slanted. 0 510(k) Premarket Notification - Traditional | Feature | Name | |---------|------| |---------|------| IPE, Image Post-processing Engine ### 6. Predicate Devices | | Predicate Devices | | | | | | | |----------------------------|--------------------------------|-----------------------------|--------------------------------|--------------------------------|------------------------------------|---------------------------|--------------------------------| | | #1 | #2 | #3 | #4 | #5 | #6 | #7 | | Device Name | GC70 | GU60A&GU6 0A-65 | GF50 | GF50A | GR40C W | GM85 | GC85A | | Classificati on Name | Stationa ry X-ray System | Stationary X- ray System | Stationa ry X-ray System | Stationa ry X-ray System | Solid State X- ray Imager | Mobile X-ray System | Stationa ry X-ray System | | Product Code | KPR | KPR | KPR | KPR | MQB | IZL | KPR | | Regulation | 21 CFR 892.168 0 | 21 CFR 892.1680 | 21 CFR 892.168 0 | 21 CFR 892.168 0 | 21 CFR 892.168 0 | 21 CFR 892.17 20 | 21 CFR 892.168 0 | | 510(K)# | K16311 5 | K173828 | K14032 6 | K15141 9 | K15340 1 | K17111 9 | K17222 9 | | 510(K) Decision Date | Dec., 07, 2016 | Jan., 12, 2018 | May, 29, 2014 | Jun., 23, 2015 | Dec., 21, 2015 | May, 12, 2017 | Nov., 22, 2017 | ### 7. Device Description GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 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, and sent to the Picture Archiving & Communication System (PACS) sever for reading images. An 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 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, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A. This submission is purposed to get 510(k) clearance for expanding the scope of the claim, cleared with K172229, from GC85A to the proposed devices, Samsung x-ray systems. The IPE, a software which has no relation with imaging chain, is applied to the proposed devices and it is evaluated that images acquired by a various imaging chain are {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is inside of a blue, rounded, oval shape. 510(k) Premarket Notification - Traditional substantially equivalent to GC85A in a non-clinical evaluation. The proposed devices with the IPE employing an advanced noise reduction algorithm are able to reduce dose of 50% for chest PA of average adult for marketing purpose. This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied and the clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction. #### 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 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 and GM85, apply the IPE with employing an advanced noise reduction algorithm, which was cleared with K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics. There is identical and nothing changed in technological characteristic between the predicate and proposed devices. {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo is in a blue rounded rectangle with the word "SAMSUNG" in white letters. The letters are bold and sans-serif. 510(k) Premarket Notification - Traditional A. Compared with Predicate Devices | Specification | Proposed Device #1 | Predicate Device #7 | Discussion | | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------| | Device Name | GC70 | GC85A | | | | Manufacturer | SAMSUNG ELECTRONICS Co., Ltd. | SAMSUNG ELECTRONICS Co., Ltd. | | | | | 510(k) Number | None | K172229 | | | 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 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. | Same as PD#1 | | | High Voltage Generator | | | | | | Type | High Frequency | High Frequency | Same as PD#1 | | | Max. Power | 82kW | 82kW | Same as PD#1 | | | Tube Voltage | 40-150kV | 40-150kV | Same as PD#1 | | | Output RANGE | Tube Current | 10-1000mA | 10-1000mA | Same as PD#1 | | | Exposure Time | 1msec-10sec | 1msec-10sec | Same as PD#1 | | AEC (Automatic Exposure Control) | Yes | | Same as PD#1 | | | APR (Anatomically Programmed Radiography) | Yes | | Same as PD#1 | | | X-ray tube | | | | | | Name | E7869X | E7869X | Same as PD#1 | | | kV range | 40-150kV | 40-150kV | Same as PD#1 | | | Max. Power | Large focus | 100kW | 100kW | Same as PD#1 | | | Small focus | 40kW | 40kW | Same as PD#1 | | Max. mA | Large focus | 1000mA | 1000mA | Same as PD#1 | | | Small focus | 500mA | 500mA | Same as PD#1 | | Anode target material | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#1 | | {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, oval-shaped background. | Collimator | | | | | | | | |----------------------------------------------------|--------------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|------------------------------------------|--------------| | Name | SDR-OGCL83U | SDR-OGCL80U | SDR-OGCL83U | Same as PD#1 | | | | | Overall Size(mm) | H212 X W306 X D179 | H212 X W300 X D179 | H212 X W306 X D179 | Same as PD#1 | | | | | Beam Limiting Blade Moving Method | Motorized /Manual | Motorized /Manual | Motorized /Manual | Same as PD#1 | | | | | Manual Operation Method | Volume | Volume | Volume | Same as PD#1 | | | | | Collimator Rotation | ±45 | ±45 | ±45 | Same as PD#1 | | | | | Beam Light Source | LED | LED | LED | Same as PD#1 | | | | | Light Field Indicator Timer | O | O | O | Same as PD#1 | | | | | | O | O | O | Same as PD#1 | | | | | Side Lamp | Laser Module | Laser Module | Laser Module | Same as PD#1 | | | | | Field Size / SID Display | Color LCD | Color LCD | Color LCD | Same as PD#1 | | | | | Detector | | | | | | | | | Name | S433 5-W | S434 3-W | S302 5-W | S433 5-W | S434 3-W | S302 5-W | Same as PD#1 | | | Csl | Csl | Csl | Csl | Csl | Csl | Same as PD#1 | | Detector Type | Indire ct | Indire ct | Indire ct | Indire ct | Indire ct | Indire ct | Same as PD#1 | | Detector Area | 14"X1 7" (345 mmX 425m m) | 17"X1 7" (425 mmX 425m m) | 10"X1 2" (245 mmX 295m m) | 14"X1 7" (345 mmX 425m m) | 17"X1 7" (425 mmX 425m m) | 10"X1 2" (245 mmX 295m m) | Same as PD#1 | | Number of pixels | 2466 X304 0 | 3036 X304 0 | 1750 X210 8 | 2466 X304 0 | 3036 X304 0 | 1750 X210 8 | Same as PD#1 | | Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#1 | | High Contrast Limiting Resolution (LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#1 | | Communication | Wired / Wirel ess | Wired / Wirel ess | Wired / Wirel ess | Wired / Wirel ess | Wired / Wirel ess | Wired / Wirel ess | Same as PD#1 | | Image Post-processing Engine | | | | | | | | | Noise reduction algorithm | Image Post-processing Engine with an advanced | | | | | | Same as PD#7 | {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. | | noise reduction algorithm | noise reduction algorithm | | |--|------------------------------|------------------------------|--| |--|------------------------------|------------------------------|--| | Specification | Proposed Device #2 | | Predicate Device #7 | Discussion | | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------| | | GU60A | GU60A-65 | | | | | Device Name | GU60A & GU60A-65 | | GC85A | | | | Manufacturer | SAMSUNG ELECTRONICS Ltd. | Co., | SAMSUNG ELECTRONICS Co., Ltd. | | | | 510(k) Number | None | | K172229 | | | | Intended Use | The GU60A & GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | | The 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. | Same as PD#2 | | | High Voltage Generator | | | | | | | Type | High Frequency | | High Frequency | Same as PD#2 | | | Max. Power | 50kW/68kW | 65kW | 82kW | Same as PD#2 | | | Tube Voltage | 40 to 150kVp | 40 to 150kVp | 40-150kV | Same as PD#2 | | | Output RANGE | Tube Current | 10 - 630mA/ 10 - 800mA | 10 - 800mA | 10-1000mA | Same as PD#2 | | | Exposure Time | 1msec- 6.3sec/ 1msec- 10sec | 1msec- 6.3sec | 1msec-10sec | Same as PD#2 | | X-ray tube | | | | | | | Name kV range | E7252X 40-150kV | | E7869X 40-150kV | Same as PD#2 | | | Max. Power | Large focus | 75kW | | 100kW | Same as PD#2 | | | Small focus | 27kW | | 40kW | Same as PD#2 | | Max. mA | Large focus | 1000mA | | 1000mA | Same as PD#2 | | | Small focus | 400mA | | 500mA | Same as PD#2 | | Anode target material | Rhenium-Tungsten | | Rhenium-Tungsten | Same as PD#2 | | | Collimator | | | | | | {14}------------------------------------------------ Image /page/14/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 slightly italicized. | Name | SDR-OGCL82U | SDR-OGCL80 U | SDR-OGCL83 U | Same as PD#2 | | | | |----------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|--------------| | Overall Size(mm) | H212 X W306 X D179 | H212 X W300 X D179 | H212 X W306 X D179 | Same as PD#2 | | | | | Beam Limiting Blade Moving Method | Motorized /Manual | Motorized /Manual | Motorized /Manual | Same as PD#2 | | | | | Manual Operation Method | Volume | Volume | Volume | Same as PD#2 | | | | | Collimator Rotation | ±45 | ±45 | ±45 | Same as PD#2 | | | | | Beam Light Source | LED | LED | LED | Same as PD#2 | | | | | Light Field Indicator Timer | O | O | O | Same as PD#2 | | | | | Side Lamp | Laser Module | Laser Module | Laser Module | Same as PD#2 | | | | | Field Size / SID Display | Color LCD | Color LCD | Color LCD | Same as PD#2 | | | | | Detector | | | | | | | | | Name | S433 5-W | S434 3-W | S302 5-W | S433 5-W | S434 3-W | S302 5-W | Same as PD#2 | | | Csl | Csl | Csl | Csl | Csl | Csl | Same as PD#2 | | Detector Type | Indire ct | Indire ct | Indire ct | Indire ct | Indire ct | Indire ct | Same as PD#2 | | Detector Area | 14"X 17" (345 mmX 425m m) | 17"X 17" (425 mmX 425m m) | 10"X1 2" (245 mmX 295m m) | 14"X 17" (345 mmX 425m m) | 17"X1 7" (425 mmX 425m m) | 10"X1 2" (245 mmX 295m m) | Same as PD#2 | | Number of pixels | 2466 X304 0 | 3036 X304 0 | 1750 X210 8 | 2466 X304 0 | 3036 X304 0 | 1750 X210 8 | Same as PD#2 | | Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#2 | | High Contrast Limiting Resolution (LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#2 | | Communication | Wired/ Wirel ess | Wired/ Wirel ess | Wired/ Wirel ess | Wired/ Wirel ess | Wired/ Wirel ess | Wired/ Wirel ess | Same as PD#2 | | Image Post-processing Engine | | | | | | | | | Noise reduction algorithm | Image Post- processing Engine with an advanced noise reduction algorithm | | | Image Post- processing Engine with an advanced noise reduction algorithm | | | Same as PD#7 | {15}------------------------------------------------ Image /page/15/Picture/1 description: The image shows the Samsung logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white, bold letters inside the oval. | Specification | | Proposed Device #3 | Predicate Device #7 | Discussion | |----------------------------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Device Name | | GF50 | GC85A | | | Manufacturer | | SAMSUNG ELECTRONICS Co., Ltd. | SAMSUNG ELECTRONICS Co., Ltd. | | | 510(k) Number | | None | K172229 | | | Intended Use | | 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 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. | Same as PD#3 | | High Voltage Generator | | | | | | Type | | High Frequency | High Frequency | Same as PD#3 | | Max. Power | | 52kW | 82kW | Same as PD#3 | | Output RANGE | | Tube Voltage 40-150kV | Tube Voltage 40-150kV | Same as PD#3 | | | | Tube Current 10-640mA | Tube Current 10-1000mA | Same as PD#3 | | | | Exposure Time 1msec-10sec | Exposure Time 1msec-10sec | Same as PD#3 | | AEC (Automatic Exposure Control) | | Yes | Yes | Same as PD#3 | | APR (Anatomically Programmed Radiography) | | Yes | Yes | Same as PD#3 | | X-ray tube | | | | | | Name | | E7252X | E7869X | Same as PD#3 | | kV range | | 40-150kV | 40-150kV | Same as PD#3 | | Max. Power | Large focus | 75kW | 100kW…