K Number

Device Name

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

Manufacturer

Gemss Healthcare Co., Ltd.

Date Cleared

2023-11-02

(224 days)

Product Code

KPR

Regulation Number

892.1680

Intended Use

The XVISION-525 diagnostic X-ray system is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.

Device Description

The XVISION-525 diagnostic X-Ray System (Models HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50) generates medical X-rays passing through the patient's body and a X-ray detector for producing radiographic images of the human anatomical structures. The XVISION-525 diagnostic X-ray system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a x-ray tube, that operates on a high-frequency inverter method. The user can select or change x-ray parameters easily using the operator control console. The AEC (Automatic Exposure Control) is an optional function to give the user control of exposure factors which can be optimized for different types of detectors selected, film or digital. The XVISION-525 X-ray system does not include a detector.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K192364

Reference Devices

K192512, K200622, K100094

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard diagnostic X-ray system with an optional Automatic Exposure Control (AEC) function. There is no mention of AI, ML, image processing software, or any features that would suggest the use of such technologies. The performance studies focus on essential performance and image quality compared to a predicate device, not on AI/ML performance metrics.

Therapeutic

No
The device is described as a "diagnostic X-ray system" used for "acquiring X-ray images" and producing "radiographic images," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "The XVISION-525 diagnostic X-ray system..." and the "Device Description" section also refers to it as a "diagnostic X-Ray System".

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components (HV generator, tube support unit, X-ray beam limiting device, patient table, wall Bucky stand, X-ray tube, operator control console) that are part of the system.

IVD (In Vitro Diagnostic)

Based on the provided information, the XVISION-525 diagnostic X-ray system is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The XVISION-525 is an X-ray imaging system. It generates X-rays that pass through the patient's body to create images of internal anatomical structures. This is an in vivo (within the living body) diagnostic method, not an in vitro method.
Intended Use: The intended use clearly states it's for "acquiring X-ray images of the desired parts of a patient's anatomy." This involves imaging the patient directly, not analyzing samples taken from the patient.

Therefore, the XVISION-525 falls under the category of medical imaging devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KPR

Device Description

The XVISION-525 diagnostic X-ray system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a x-ray tube, that operates on a high-frequency inverter method.

The user can select or change x-ray parameters easily using the operator control console. The AEC (Automatic Exposure Control) is an optional function to give the user control of exposure factors which can be optimized for different types of detectors selected, film or digital.

The XVISION-525 X-ray system does not include a detector.

Mentions image processing

Yes, "The XVISION-525 diagnostic X-ray system does not include image processing software."

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

patient's anatomy

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

Performance Testing - Bench: Essential performance for diagnostic X-ray system was verified according to the FDA recognized standard IEC 60601-2-54: 2018. Image Quality and Radiation Dose Test was also conducted with the predicate device.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192364

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K192512, K200622, K100094

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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.

November 2, 2023

Gemss Healthcare Co., Ltd. % Mr. Jiho Park RA Manager 1F, 822, Bogwang-ro, Gwangtan-myeon Paju-si, Gyeonggi-do 10952 SOUTH KOREA

Re: K230800

Trade/Device Name: Xvision-525, Horizon, Hi-300, Saturn-f Pf32, Saturn-f Pf40, Saturn-f Pf50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 21, 2023 Received: September 21, 2023

Dear Mr. Park:

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Indications for Use

510(k) Number (if known) K230800

Device Name

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is in orange, and the word "HEALTHCARE" is in gray. The logo is simple and modern.

510(k) Summary K230800

510(k) Submission: K230800

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: September 16, 2023

1. Applicant / Submitter

GEMSS HEALTHCARE CO., LTD. -
Address: 1F, 822, Boqwang-ro, Gwangtan-myeon, Paju-si, Gyeonqqi-do, 10952, Republic of Korea
-Tel: +82-31-906-9017 Fax: +82-31-906-9019 Email:olivia@gemss-healthcare.com

2. Official Correspondent

Dave Kim, MBA
Mtech Group LLC

7505 Fannin St. Suite 610, Houston, TX 77054

Tel: 713-467-2607, Email: davekim@mtechgroupllc.com

3. Device Information

Trade/Device Name: XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
। Requlation Number: 21CFR 892.1680
Regulation Name: Stationary x-ray system ।
Device Class: Class II ।
Product Code: KPR ।

4. Predicate Device

K Number: K192364
Manufacturer: DRGEM Corporation ।
Trade Name: GXR-Series Diagnostic X-Ray System (Model: GXR-S) -
Requlation Number: 21CFR 892.1680 ।
Regulation Name: Stationary x-ray system -
Device Class: Class II -
Product Code: KPR

Image /page/4/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is written in large, orange, sans-serif font. Below the word "GEMSS" is the word "HEALTHCARE" written in a smaller, gray, sans-serif font. The logo is simple and modern.

5. General Description

The XVISION-525 X-ray system does not include a detector.

6. Indication for use

7. Comparison of the modified device to the cleared device

| Descriptive

Information	Subject Device	Predicate Device	Comparison
Manufacturer	GEMSS HEALTHCARE CO.,
LTD.	DRGEM Corporation	-
Device Name	Category: X-ray
equipment for
diagnosis
Product: XVISION-525
Model: XVISION-525,
HORIZON, HI-300, HI-
500, SATURN-F PF32,
SATURN-F PF40,
SATURN-F PF50	Category: Diagnostic
X-Ray System
Product: GXR-Series
Diagnostic X-Ray
System
Model: GXR-S	-
510(k) number	TBD	K192364	-
Regulatory
Number	21CFR 892.1680	21 CFR 892.1680	Same
Product Code	KPR	KPR	Same
Regulatory Class	2	2	Same
		The XVISION-525
diagnostic X-ray system is
a stationary X-ray imaging
system, for the purpose of
acquiring X-ray images of
the desired parts of a
patient's anatomy. This
device is not intended for
mammography or bone
density applications.	The GXR-Series Diagnostic
X-Ray System, (Models
GXR-SD, GXR-S, SGXR-S,
FDR Smart FGXR-S), is a
stationary X-ray imaging
system, for the purpose of
acquiring X-ray images of
the desired parts of a
patient's anatomy. This
device is not intended for
mammography or bone
density applications.	Similar
(Note 1)
Indications for
Use
Operation		For conventional
radiography, an x-ray
beam is generated and
passed through a patient
to a piece of film or a
radiation detector,
producing an image.
Different soft tissues
attenuate x-ray photons
differently, depending on
tissue density; the denser
the tissue, the whiter
(more radiopaque) the
image. A single image is
recorded for later
evaluation.	For conventional
radiography, an x-ray
beam is generated and
passed through a patient
to a piece of film or a
radiation detector,
producing an image.
Different soft tissues
attenuate x-ray photons
differently, depending on
tissue density; the denser
the tissue, the whiter
(more radiopaque) the
image. A single image is
recorded for later
evaluation.	Same
X-ray
Generat
or	Models	PXR-401B, PXR-401BB,
PXR-501B, PXR-501T,
PXR-501TA	GXR-40, GXR-52,
GXR-68, GXR-82
GXR-C32, GXR-C40,
GXRC52
	Output
Power	40kW, 50kW	32kW, 40kW, 52kW,
68kW, 82kW
	kV
Range	40~125kV,
40~150kV	40~125kV,
40~150kV	Similar
(Note 2)
	mA
Range	10~500mA
10~630mA	GXR-32=10 to 400mA
GXR-40=10 to 500mA
GXR-52=10 to 640mA
GXR-68=10 to 800mA
GXR-82=10 to 1,000mA
	Line
voltage	220/230/240 VAC
100-120/220-240 VAC
380/400/440 VAC	220-230 VAC
380/400/480 VAC
	Tube Stand	Floor mount Type
Floor Ceiling Type	Floor mount Type
Floor Ceiling Type	Same
(Note 3)

Image /page/5/Picture/0 description: The image shows the GEMSS Healthcare logo. The word "GEMSS" is in orange, and the word "HEALTHCARE" is in gray. The logo is simple and modern.

Image /page/6/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is written in large, orange, sans-serif font. Below the word "GEMSS" is the word "HEALTHCARE" written in a smaller, gray, sans-serif font. The logo is simple and modern.

| Bucky Table | 4-way Tabletop Patient
Table | 4-way Tabletop Patient
Table |
|----------------------|--------------------------------------|------------------------------------------------------------------------------|
| Wall Bucky
Stand | Vertical Movement | Vertical Movement |
| Image
Acquisition | Detector not supplied with
system | Detector not supplied with
system (for GXR-S, SGXRS,
FDR Smart FGXR-S) |

Note 1.

The Predicate device, GXR-Series Diagnostic X-Ray System has several models (GXR-SD, GXR-S, SGXR-S, FDR Smart FGXR-S). GXR-SD, GXR-S, FDR Smart ad FGXR-S do not have a detector. XVISION-525 diagnostic X-ray system, the subject device does not include a detector in its final product offering for the 510(k) clearance.

Example of digital X-ray detectors compatible with the XVISION-525 diagnostic X-ray system are provided below:

Detector manufacture : Carestream Health, Inc -
Detector model : Focus 35C (FDA, K192512), Focus 43C (FDA, K200622) -
- -Image Processing Software: Image Suite (FDA, K100094)

Note 2.

The X-ray generator specifications are different from the predicate device.

1. Models: The predicate device has 7 different X-ray generator models depending on the output power, line voltage and kV range. We compare the subject device's X-ray generator models (PXR-401B, PXR-401BB, PXR-501T, PXR-501T, PXR-501TA) with GXR-40 and GXR-52 which has similar specifications.
1. Output:
Model PXR-401B and PXR-401BB have the output power, 40kW. It is the same as the predicate device's X-ray generator, GXR-40 (40kW). Model PXR-501B, PXR-501T and PXR-501TA have the output power, 50kW. It is similar to the predicate device's X-ray generator, GXR-52 (52kW).
Model PXR-401B and PXR-401BB has the kV rage, 40~~125kV. It is the same as the predicate device's X-ray generator, GXR-40c (40~~125kV). Model PXR-501B, PXR-501T and PXR-501TA has the kV rage, 40~~150kV. It is the same as the predicate device's Xray generator, GXR-52 (40~~150kV).
Model PXR-401B and PXR-401BB has the mA range, 10~~500mA. It is the same as the i predicate device's X-ray generator, GXR-40c (10~~500mA). Model PXR-501B, PXR-501T and PXR-501TA has the kV range, 10~~630mA. It is similar to the predicate device's Xray qenerator, GXR-52 (10~~640mA).

Image /page/7/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is in large, orange, sans-serif font. Below that, in a smaller, gray, sans-serif font, is the word "HEALTHCARE". The logo is simple and modern.

The subject device has been tested and verified about the safety and performance according to IEC 60601-1-3:2021, IEC 60601-2-28:2017 and IEC 60601-2-54: 2022.

1. Line voltage: Line voltage depends on the model.
Model PXR-401B and PXR-501B have the input power (Single phase 220/230/240VAC).
Model PXR-401BB has the input power (Single phase, 100-120/220-240VAC).
Model PXR-501T has the input power (Three phase 380/400/440VAC).
Model PXR-501TA has input power (Three phase 220/230/240VAC).

The predicate device's X-ray generator is connected to the line voltage 220-230VAC or 380/400/480VAC depends on the model

The subject device has been tested and verified about the electrical safety according to IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-28:2017 and IEC 60601-2-54:2018.

EMC test also has been conducted according to IEC 60601-1-2:2020

Note 3.

Tube Stand, Bucky Table and Wall Bucky Stand have the same purpose and movement as the predicate device.

The electrical and mechanical specification have been tested and verified according to IEC 60601-1:2005+A1:2012+A2:2020 and IEC 60601-2-54:2018.

EMC test also has been conducted according to IEC 60601-1-2:2020.

8. Software

The software is a firmware to control the X-ray Equipment for diagnosis (Models: XVISION-525). It is considered as Moderate Level of Concern. The primary function of the software is the operation of X-ray equipment for image acquisition. The user operates the X-ray Operation Unit to control the X-ray Control Unit. In X-ray Operation Unit, user can use Power On / Off, X-ray setting, irradiation, and options of X-ray Control Unit. The X-ray control unit carries out the X-ray setting and irradiation with the information transmitted from the X-ray operation.

The XVISION-525 diagnostic X-ray system does not include image processing software.

The software validation report was prepared in accordance with "FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".

9. Electrical Safety and Electromagnetic Compatibility

Electrical Safety was verified according to the FDA recognized standards.

Image /page/8/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is written in orange, block letters. Below the word "GEMSS" is the word "HEALTHCARE" written in gray, block letters.

IEC 60601-1:2005+A1:2012+A2:2020 -
-IEC 60601-1-3:2008+A1:2013,
-IEC 60601-2-28:2017
-IEC 60601-2-54:2018

EMC was verified according to the FDA recognized standard.

IEC 60601-1-2:2014+A1:2020 -

10. Performance Testing - Bench

Essential performance for diagnostic X-ray system was verified according to the FDA recognized standard IEC 60601-2-54: 2018 Image Quality and Radiation Dose Test was also conducted with the predicate device.

11. Conclusion

The major consideration such as intended use and principle of operation, general function and application is the same as the predicate device. Although there are some differences, the safety and performance test reports are supported to the safety and effectiveness of the subject device. The test results show that the subject device does not raise any new potential safety and performance risks.

We conclude that the subject device is substantially equivalent to the predicate devices.