Who is the manufacturer of GC70?

Samsung Electronics Co., Ltd. filed the 510(k) submission for GC70 (K182647).

What is the FDA product code for GC70?

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?

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

What are the predicate devices for GC70?

GC85A (K181629); GC70 (K180543).

Who can help prepare an FDA 510(k) submission like GC70?

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

K182647 · Samsung Electronics Co., Ltd. · KPR · Oct 24, 2018 · Radiology

Device Facts

Record ID	K182647
Device Name	GC70
Applicant	Samsung Electronics Co., Ltd.
Product Code	KPR · Radiology
Decision Date	Oct 24, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended Use

The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Story

GC70 is a stationary digital X-ray imaging system for general radiography. System captures X-ray images by transmitting X-rays through patient anatomy to a detector; detector converts X-rays to electrical signals. Signals are processed by S-station (Operation Software) via amplification and digital conversion; saved as DICOM files. Image Post-processing Engine (IPE) tunes images before transmission to PACS for clinical review. Components include high voltage generator, ceiling suspension, X-ray tube, collimator, detector, wall stand, patient table, and workstation. Operated by qualified doctors or technicians in clinical settings. Added features include S-Enhance for clarity of foreign bodies/stones, Pediatric Exposure Management (PEM) for weight-based exposure protocols, and Remote View for image access on secondary PCs. Output assists clinicians in diagnostic decision-making by providing high-quality radiographic images.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including electrical, mechanical, and environmental safety (ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30/31) and imaging performance metrics (MTF and DQE per IEC 62220-1).

Technological Characteristics

Stationary digital X-ray system. Components: High Voltage Generator, ceiling suspension, X-ray tube, collimator, CsI indirect detector, wall stand, patient table. Connectivity: DICOM standard, wired/wireless detector communication. Software: S-station OS with IPE. 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 for use by qualified/trained doctors or technicians. Not for mammographic applications.

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

GC85A (K181629)
GC70 (K180543)

Related Devices

K163115 — GC70 · Samsung Electronics Co., Ltd. · Dec 7, 2016
K143029 — Digital Diagnostic X-ray System (GC80) · Samsung Electronics Co., Ltd. · Feb 4, 2015
K182622 — GU60A, GU60A-65 · Samsung Electronics Co., Ltd. · Oct 23, 2018
K181629 — GC85A · Samsung Electronics Co., Ltd. · Jul 20, 2018
K140334 — XGEO GC80 · Samsung Electronics Co., Ltd. · May 28, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Samsung Electronics Co., Ltd. Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si. 16677 KR Re: K182647 Trade/Device Name: GC70 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 21, 2018 Received: September 24, 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 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) for October 24, 2018 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 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, Image /page/1/Picture/5 description: The image shows the name Michael D. O'hara -S in large font on the left side of the image. On the right side of the image is a digital signature with the name Michael D. O'hara -S. The signature includes the date 2018.10.24 07:38:20-04'00'. Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K182647 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. > 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) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ 510(k) Premarket Notification - Special # 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: September 21, 2018 ### 2. Submitter - A. Company Name: SAMSUNG ELECTRONICS Co., Ltd. - B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea ### 3. Primary Contact Person - Name: JAESANG NOH & CHUNSIN KIM A. - Title: Regulatory Affairs, Senior Professional B. - C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437 - D. FAX Number: +82-31-200-6401 - E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com ப் ### 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 ய் ### 5. Proposed Device - A. Trade Name: GC70 - B. Device Name: GC70 - C. Common Name: Digital Diagnostic X-ray System - D. Regulation Name: Stationary X-ray system - E. Product Code: KPR - Regulation: 21 CFR 892.1680 ட் ### 6. Predicate Devices | | Predicate Device #1 | Predicate Device #2 (Primary Predicate) | |----------------------|----------------------------|--------------------------------------------| | Device Name | GC85A | GC70 | | Classification Name | Stationary X-ray System | Stationary X-ray System | | Product Code | KPR | KPR | | Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 | | 510(K)# | K181629 | K180543 | | 510(K) Decision Date | July 20, 2018 | May 24, 2018 | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is placed inside a blue, oval-shaped background. 510(k) Premarket Notification - Special ### 7. Device Description The GC70 digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray 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. The GC70 digital X-ray imaging system consists of HVG (High Voltage Generator), ceiling suspension, X-ray tube, collimator, detector, wall stand, patient table, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, foot switch, barcode scanner, auto-stitching stand, weight distribution cap and workstation for S-station including Image Post-processing Engine (IPE). The GC70 digital X-ray imaging system was previously cleared under K180543, and some hardware options and three software features are added to the predicate device GC70. The changes are as follows: - Two High Voltage Generators - . Two detectors - . Slim wall stand - . Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View - The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process. - Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients. - The Remote view function provided images on another PC, not just on the device. #### 8. Intended Use The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. - 9. Summary of Technological characteristic of the proposed device compared with {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The background is in the shape of an oval that is tilted slightly to the right. 510(k) Premarket Notification - Special #### the predicate devices The proposed device GC70 does not alter the intended use or the fundamental scientific technology and remains within the same classification for the same intended use as the predicate devices #1 and 2 because the proposed device GC70 uses the same X-ray generators, the same detectors, the similar wall stand, the same software features called as S-Enhance, PEM and Remote View of the predicate device GC85A, which were cleared with K181629, as a selective option of X-ray configuration. Verification and validation testing for these changes were successfully conducted in accordance with Samsung Design Change Process. The following tables compare the main technological characteristics of the proposed device with the predicate devices to substantiate equivalence. #### A. Comparing with Predicate Devices The components and software features added to the proposed device are identical or similar to the predicate devices, which do not show significant difference in safety and effectiveness. | Specification | Predicate Device #1 | Predicate Device #2 (Primary Predicate) | Proposed Device | Discussion | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Device Name | GC85A | GC70 | GC70 | | | Manufacturer | SAMSUNG ELECTRONICS Co., Ltd. | SAMSUNG ELECTRONICS Co., Ltd. | SAMSUNG ELECTRONICS Co., Ltd. | | | 510(k) Number | K181629 | K180543 | None | | | Appearances | Image: GC85A | Image: GC70 | Image: GC70 | Same as PD#2 | | Intended Use | The GC85A digital X-ray imaging system is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | 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#2 | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval. 510(k) Premarket Notification - Special | Manufacturer Contents | GC85A (K181629) | GC70 (K180543) | GC70 | Discussion | | | | | | | | | |-------------------------------------------------|--------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------|--------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------| | (1)High | Voltage Generator | | | | | | | | | | | | | Model Number | G X R- 82 | G X R- 52 | Z R 75 P N 80 | Z R 75 P N 50 | GXR-82 | GXR-52 | G X R- 82 | G X R- 52 | Z R 75 P N 80 | Z R 75 P N 50 | | | | | Max. Power | 82 k W | 52 k W | 80 k W | 50 k W | 82kW | 52kW | 82 k W | 52 k W | 80 k W | 50 k W | Same as PD#1&2 | | Output RANGE | Tube Voltage | 40 - 15 Ok V | v4 0- 15 Ok V | 40 - 15 Ok V | 40 - 15 Ok V | 40- 150kV | v40- 150kV | 40 - 15 Ok V | v4 0- 15 Ok V | 40 - 15 Ok V | 40 - 15 Ok V | Same as PD#1&2 | | | Tube Current | 10 - 10 00 m A | 10 - 64 00 m A | 10 - 10 00 m A | 10 - 63 00 m A | 10- 1000m A | 10- 640mA | 10 - 10 00 m A | 10 - 64 00 m A | 10 - 10 00 m A | 10 - 63 00 m A | Same as PD#1&2 | | | Exposure Time | 1 m se c- 10 se c | 1 m se c- 10 se c | 1 m se c- 10 se c | 1 m se c- 10 se c | 1msec- 10sec | 1msec- 10sec | 1 m se c- 10 se c | 1 m se c- 10 se c | 1 m se c- 10 se c | 1 m se c- 10 se c | Same as PD#1&2 | | AEC (Automatic Exposure Control) | | Yes | | | | Yes | | Yes | | | | Same | | APR (Anatomically Programmed Radiography) | | Yes | | | | Yes | | Yes | | | | Same | | Manufacturer Contents | | GC85A (K181629) | GC70 (K180543) | GC70 | Discussion | |---------------------------------|-----------|---------------------|-----------------------|-------------------|------------------------------------------------------------------------------------| | (2) Wall Stand | | | | | | | Model number | | SDR- OGST 80U | SDR- OGST 73A/B | SDR- OGST73A/B | SDR- OGST73A/ B is the same as PD#1&2 and SDR- OGST73C is new | | Vertical Movement | Mechanism | Motorized | Motorized | Motorized | Same | | | Range(mm) | 280~1 850 | 412~1 838 | 412~1838 | Same as PD#1&2 | | Detector/tube servo coupling | | Yes | Yes | Yes | Same | {7}------------------------------------------------ Image /page/7/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 - Special | Manufacturer Contents | | GC85A (K181629) | GC70 (K180543) | GC70 | Discussion | | |------------------------------|-------------------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------------------|-----------------|----------------------------------------------------------------------| | Detector | Tilting | Motorized | Motorized | Motorized | None | SDR-OGST73A/ B is the same as PD#1&2 and SDR-OGST73C is new | | | | 20~+90 | 20~+90 | 30~+90 | None | SDR-OGST73A/ B is the same as PD#1&2 and SDR-OGST73C is new | | AEC | | Conventional | Conventional | Conventional | Same | | | Grid | Lines/cm | 85/92 | 85/92 | 85/92 | Same | | | | Grid mechanism | Stationary | Stationary | Stationary | Same | | | | Removability | Removable | Removable | Removable | Same | | | Detector Support Mounting | | Floor | Floor | Floor | Same | | | Patient Support Device | | Patient handgrips, lateral support bar | Patient handgrips, lateral support bar | Patient handgrips, lateral support bar | Same | | | Manufacturer Contents | GC85A (K181629) | GC70 (K180543) | | GC70 | Discussion | | | (3) Detector | | | | | | | | Name (Model Number) | S4335-W S4343-W S3025-W S4335-AW S4343-AW | S4335-W S4343-W S3025-W | | S4335-W S4343-W S3025-W S4335-AW S4343-AW | Same as PD#1 | | | | S4335-AW S4343-AW | S4335-W | S4343-W | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Detector Type | Csl Indirect | Csl Indirect | | Csl Indirect | Same | | | Detector Area | 14"X17 "(345m | 17"X17 "(425m | | 14"X17 "(345m 17"X17 "(425m | Same | | {8}------------------------------------------------ Image /page/8/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. The logo is simple and recognizable. 510(k) Premarket Notification - Special | Manufacturer Contents | GC85A (K181629) | GC85A (K181629) | GC70 (K180543) | GC70 (K180543) | GC70 | GC70 | Discussion | |-------------------------------------------------|-----------------------------|------------------------------------------|-----------------------------|------------------------------------------|-----------------------------|------------------------------------------|-----------------| | | mX425 mm) | mX425 mm) | mX425 mm) | mX425 mm) | mX425 mm) | mX425 mm) | | | Number of pixels | 2466X 3040 | 3036X 3040 | 2466X 3040 | 3036X 3040 | 2466X 3040 | 3036X 3040 | Same | | Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same | | High Contrast Limiting Resolution (LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same | | Communication | Wired / Wireless s | Wired / Wireless s | Wired / Wireless s | Wired / Wireless s | Wired / Wireless s | Wired / Wireless s | Same | | Dust/Water- resistance | IP54 | | IPx1 | | IP54 | | Same as PD#1 | | Max.load capacity | 400 kg for uniform load, | | 150 kg for uniform load, | | 400 kg for uniform load, | | | | | 200 kg for local | | 100 kg for local | | 200 kg for local | | Same as PD#1 | | | load (40 | mm in diameter disk at the center) | load (40 | mm in diameter disk at the center) | load (40 | mm in diameter disk at the center) | PD#1 | | Manufacturer Contents | GC85A (K181629) | GC70 (K180543) | GC70 | Discussion | |-----------------------|--------------------|-------------------|-------------|-----------------| | (4) Software Features | | | | | | Feature Names | SimGrid | SimGrid | SimGrid | Same | | | S-Guide | S-Guide | S-Guide | Same | | | S-Enhance | - | S-Enhance | Same as PD#1 | | | PEM | - | PEM | Same as PD#1 | | | S-DAP | S-DAP | S-DAP | Same | | | S-Align | S-Align | S-Align | Same | | | S-Share | S-Share | S-Share | Same | | | BSI | BSI | BSI | Same | | | Remote View | - | Remote View | Same as PD#1 | #### B. Safety, EMC and Performance Data 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 {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance. #### 510(k) Premarket Notification - Special Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device. #### D. Clinical data The application of these hardware options and software features, cleared with K181629, to the proposed device GC70 do not require clinical data. #### E. Conclusions The non-clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed devices.