DRE Duo

K260482 · Jpi Healthcare Co, Ltd. · KPR · Jun 15, 2026 · Radiology

Device Facts

• Record ID: K260482
• Device Name: DRE Duo
• Applicant: Jpi Healthcare Co, Ltd.
• Product Code: KPR · Radiology
• Decision Date: Jun 15, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Indications for Use

The DRE Duo is intended for use in hospitals and clinical settings under the supervision of qualified medical professionals. The system is intended to generate X-ray radiation for general radiographic examinations of the human body. The system is designed to be used in conjunction with external image receptors, such as film-based radiography systems or compatible digital detectors, which are not part of the system.

Device Story

DRE Duo is a stationary diagnostic X-ray system; generates X-ray radiation for general radiographic examinations. System comprises X-ray generator, X-ray tube, collimator, patient support components (bucky table/wall stand), and control console. Used in hospitals, clinics, and imaging centers; operated by qualified medical professionals or radiologic technologists. Device interfaces with external image receptors (film-based or digital detectors) to capture images. Healthcare providers use system controls to manage exposure and dose according to clinical protocols. Output is X-ray radiation directed at patient anatomy; resulting images assist in diagnostic decision-making. Benefits include standardized, reliable radiographic imaging for patient diagnosis.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through non-clinical performance testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), radiation safety (IEC 60601-1-3, IEC 60601-2-54), and functional verification of radiation output (reproducibility, linearity, and accuracy of kV/mA/time/mAs). Image quality was validated using MTF and DQE metrics with integrated compatible flat panel detectors.

Technological Characteristics

Stationary radiographic X-ray system. Components: High-frequency generator (40/50 kW), X-ray tube (Canon E7239X/E7242X/E7252X), collimator (LED light source), patient table, and console. Total filtration: 2.9 mm Al equivalent. Connectivity: Console-based control. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, ISO 14971, ISO 13485. Software: Compliant with FDA guidance for device software functions and cybersecurity.

Indications for Use

Indicated for general radiographic examinations of the human body in hospital and clinical settings under the supervision of qualified medical professionals.

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

• GXR-Series Diagnostic X-Ray System (K192364)

Submission Summary (Full Text)

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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION

June 15, 2026

Jpi Healthcare Co, Ltd.
% Jeong DoAn
Regulatory affairs Manager
Woolim E-Biz Center 608-Ho,28, Digital-Ro 33gil, Guro-Gu
SEOUL, 08377
REPUBLIC OF KOREA

Re: K260482

Trade/Device Name: DRE Duo
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary X-Ray System
Regulatory Class: Class II
Product Code: KPR
Dated: May 11, 2026
Received: May 11, 2026

Dear Jeong Doan:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260482 - Jeong Doan

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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K260482 - Jeong Doan

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

# Indications for Use

510(k) Number (if known)
K260482

Device Name
DRE Duo

Indications for Use (Describe)

The DRE Duo is intended for use in hospitals and clinical settings under the supervision of qualified medical professionals. The system is intended to generate X-ray radiation for general radiographic examinations of the human body. The system is designed to be used in conjunction with external image receptors, such as film-based radiography systems or compatible digital detectors, which are not part of the system.

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.*

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FORM FDA 3881 (6/20)

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PSC Publishing Services [phone] EF

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510(k) number: K260482


# DRE Duo
## 510(k) Summary

### 1. Submission

Name : JPI Healthcare Co.,Ltd.

Address: 608-ho, 28, Digital-ro 33-gil, Guro-gu, 08377 Seoul, Korea

Telephone: [phone]

Fax: [phone]

Contact: Do An Jeong

Website: http://www.jpi.co.kr/

Submission number : K260482

### 2. Correspondent

Name : JPI Healthcare Solutions, Inc

Address : 3555 Veterans Memorial Highway Unit D Ronkonkoma NY 11779

United States

Telephone : [phone]

Contact : Jorge Solano

Email : Jorge.solano @jpihealthcare.com

### 3. Date Prepared

05/11/2026

### 4. Device identification

Product Name: DRE Duo

Model Name:

| DRE Duo Model | JPI-DRED-DCN/01 | JPI-DRED-ECN/01 | JPI-DRED-BDN/01 | JPI-DRED-BGN/01 |
| --- | --- | --- | --- | --- |
| Generator Model | PSG-HR40 | | PSG-HR50 | VZW2556 RB2 |
| Generator Output Power | 40kW | | 50kW | |
| X-ray Tube Model | E7239X | E7242X | E7252X | |

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510(k) number: K260482---

Common Name: Diagnostic X-ray system

Regulation Number: 21 CFR 892.1680

Regulation Name: Stationary X-ray System

Regulatory Class: II

Product Code: KPR

## 5. Predicate Device

Product Name : GXR-Series Diagnostic X-Ray System

510(k) Number : K192364

Regulation Number: 21 CFR 892.1680

Regulation Name: Stationary X-ray System

Regulatory Class: II

Product Code: KPR

## 6. Device description

The DRE Duo is a Diagnostic X-ray system intended for use in general radiographic examinations of the human body.

It is designed to be used in conjunction with compatible X-ray detectors or film/screen cassettes, serving as a replacement for conventional film- or screen-based radiography systems in general diagnostic procedures.

The DRE Duo interfaces with an X-ray generator to support appropriate control of exposure and dose in accordance with clinical protocols. The system is intended for use in hospital or clinical environments under the supervision of licensed medical practitioners or qualified radiologic technologists

## 7. Indications for use

The DRE Duo is intended for use in hospitals and clinical settings under the supervision of qualified medical professionals.

The system is intended to generate X-ray radiation for general radiographic examinations of the human body. The system is designed to be used in conjunction with external image receptors, such as film-based radiography systems or compatible digital detectors, which are not part of the system.

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510(k) number: K260482

## 8. Substantial equivalence

### 8.1 General Information

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Device Name** | DRE Duo | GXR-S(GXR-52) | GXR-S(GXR-40) | Not applicable |
| **Predicate Family** | N/A | GXR-Series Diagnostic X-Ray System (K192364) | Same family | Not applicable |
| **Manufacturer** | JPI Healthcare Co., Ltd. | DRGEM Corporation | DRGEM Corporation | Administrative difference only |
| **Regulation Number** | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | Same |
| **Regulation Name** | Stationary X-ray System | Stationary X-ray System | Same | Same |
| **Product Code** | KPR | KPR | Same | Same |
| **Regulatory Class** | II | II | Same | Same |
| **Device Type** | Diagnostic X-ray system | Diagnostic X-ray system | Same | Same |

### 8.2 Intended Use and Use Environment

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Intended Use / Indications for Use** | The DRE Duo is intended for use in hospitals and clinical settings under the supervision of qualified medical professionals. The system is intended to generate X-ray radiation for general radiographic examinations of the human body. The system is designed to be used in conjunction with external image receptors, such as film-based radiography systems or compatible digital detectors, which | Stationary diagnostic X-ray imaging system for acquiring X-ray images of desired parts of a patient's anatomy. | Same general family intended use | Same intended use; wording difference only |

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510(k) number: K260482

| | are not part of the system. | | | |
| --- | --- | --- | --- | --- |
| **Intended Users** | Qualified medical professionals | Qualified medical professionals | Same | Same |
| **Use Environment** | Hospitals, clinics, imaging centers, and healthcare facilities | Hospitals, clinics, imaging centers, and healthcare facilities | Same | Same |

### 8.3 Fundamental Scientific Technology

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Fundamental Technology** | Stationary radiographic X-ray system using an X-ray generator, X-ray tube, collimator, patient positioning/support components, and external image receptor | Stationary radiographic X-ray system using an X-ray generator, X-ray tube, collimator, patient positioning/support components, and external image receptor-based imaging workflow | Same fundamental technology | Same fundamental technology |
| **Generator Type** | High-frequency X-ray generator | High-frequency X-ray generator | Same | Same |
| **Radiography Mode** | Radiography mode | Radiography mode | Same | Same |

### 8.4 System Configuration

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Principal Components** | X-ray tube, generator, collimator, tube stand, wall bucky stand, patient table, control console | X-ray tube, generator, collimator, tube stand, wall bucky stand, patient table, control console | Same family architecture | Same principal system architecture |
| **Patient Support Components** | Bucky table / patient table, wall bucky stand, tube stand | PBT series tables, WBS series wall bucky stand, TS series tube stand | Other table/support options within family | Mechanical configuration difference only |
| **Console / Controller** | Console-based system control | Membrane console / touch console / interface module as applicable | Same family concept | Engineering configuration difference only |

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510(k) number: K260482

## 8.5 Generator Characteristics

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Generator Model** | VZW2556RB2, PSG-HR40, PSG-HR50 | GXR-52 | GXR-40 | Engineering/configuration difference only |
| **Output Class** | 40 kW / 50 kW | 52 kW | 40 kW | Minor variation only |
| **Line Power / Phase** | 220–240 VAC, 50/60 Hz, 1Ø; 380/400/480 VAC, 50/60 Hz, 3Ø | 380/400/480 VAC, 50/60 Hz, 3Ø | 220–230 VAC, 50/60 Hz, 1Ø or 380/400/480 VAC, 50/60 Hz, 3Ø | Minor variation only |
| **kV Range** | 40–150 kV | 40–150 kV | 40–125 kV (optional 150 kV) | Minor variation only |
| **mA Range** | 10 to 500 / 630 mA depending on model | 10 to 640 mA | 10 to 500 mA | Minor variation only |
| **Timer Range** | 0.001 to 6.3 sec / 10 sec, depending on model | 0.001 to 10 sec | 0.001 to 10 sec | Minor variation only |
| **mAs Range** | 0.1 to 320 mAs / 0.4 to 630 mAs, depending on model | 0.1 to 500 mAs (optional to 1,000 mAs) | 0.1 to 500 mAs | Minor variation only |

## 8.6 X-ray Tube Characteristics

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Tube Model** | CANON E7239X, CANON E7242X, CANON E7252X | CANON E7252X | CANON E7239X, CANON E7242X | Same |
| **Focal Spot Size** | 1.0/2.0 mm, 0.6/1.5 mm, 0.6/1.2 mm | 0.6/1.2 mm | 1.0/2.0 mm, 0.6/1.5 mm | Same |
| **Maximum kV** | 125 kV / 150 kV | 150 kV | 125 kV | Same |
| **Anode Angle** | 16°, 14°, 12° | 12° | 16°, 14° | Same |
| **Inherent Filtration** | 0.9 mmAl/75 kV | 0.9 mmAl/75 kV | 0.9 mmAl/75 kV | Same |
| **Heat Capacity** | 140 kHU, 200 kHU, 300 kHU | 300 kHU | 140 kHU, 200 kHU | Same |

## 8.7 Collimator Characteristics

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Collimator Model** | CRUX FR04, CRUX FR10 | DXC-RML, R302MLP/A# | R108, DXC-RML | Engineering/configuration difference only |
| **Field Shape** | Square X-ray field | Square X-ray field | Square X-ray field | Same |
| **Maximum Field** | 43.5 × 43.5 cm / | 44 × 44 cm / | 43 × 43 cm / | Minor variation only |

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510(k) number: K260482

| **Size** | 43 × 43 cm | 48 × 48 cm | 44 × 44 cm | |
| --- | --- | --- | --- | --- |
| **Maximum kV** | 150 kV | 150 kV | 150 kV | Same |
| **Inherent Filtration** | 1.0 mm Al / 75 kV | Min. 2.0 mm Al eq. at 75 kV | Min. 2.0 mm Al eq. at 75 kV | Engineering/configuration difference only |
| **Additional Filtration (Final production configuration)** | 1.0 mm Al | Not separately specified in this summary | Not separately specified in this summary | Clarification of subject device configuration only |
| **Total Filtration (Final production configuration)** | 2.9 mm Al equivalent | Not separately specified in this summary | Not separately specified in this summary | Difference dose not raise new questions of safety or effectiveness |
| **Light Source** | LED Lamp | LED Lamp | LED Lamp | Same |

Note: The filtration values listed for the subject device in Sections 8.6 and 8.7 represent component-level inherent filtration only and do not by themselves represent the total system filtration. The X-ray tube provides 0.9 mm Al inherent filtration and the collimator provides 1.0 mm Al inherent filtration, resulting in 1.9 mm Al of component inherent filtration. In addition, the final production configuration of the subject device includes an additional 1.0 mm Al filter. Accordingly, the total filtration of the subject device is 2.9 mm Al equivalent. Performance testing was conducted using the final production configuration with total filtration of 2.9 mm Al equivalent.

### 8.8 Patient Table / Support Structure

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Patient Support / Table Configuration** | 4-way or 6-way bucky table depending on configuration | PBT series patient table depending on configuration | Other family table options | Mechanical design difference only |

### 8.9 Standards and Compliance

| Item | Subject Device | Primary Predicate Device | Supporting Predicate Configurations | Impact of Differences |
| --- | --- | --- | --- | --- |
| **Electrical Safety** | IEC 60601-1, IEC 60601-1-2 | Same device category standards | Same | Same |
| **Radiation Safety** | IEC 60601-1-3, IEC 60601-2-54 | Same device category standards | Same | Same |
| **Human Factors** | IEC 62366 / IEC 60601-1-6, as applicable | Same device category standards | Same | Same |
| **Risk Management** | ISO 14971 | Same device category expectations | Same | Same |
| **Quality System** | ISO 13485 | Same device category expectations | Same | Same |

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510(k) number: K260482

| **Software** | FDA Guidance: Content of Premarket Submissions for Device Software Functions (June 2023) | Same device category expectations | Same | Same |
| --- | --- | --- | --- | --- |
| **Cyber Security** | **Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions** *Guidance for Industry and Food and Drug Administration Staff* **February 2026** | Same device category expectations | Same | Same |

## 9. Performance Validation Supporting Substantial Equivalence

Substantial equivalence is supported not only by comparison of intended use and technological characteristics, but also by performance validation demonstrating that the subject device performs safely and effectively for its intended use.

The subject device performance validation included, as applicable:

- Electrical safety testing
- Electromagnetic compatibility testing
- Radiation safety / essential performance testing
- Radiation output reproducibility
- Radiation output linearity
- Accuracy of kV, mA, exposure time, and mAs
- Mechanical and functional verification
- Risk management verification of relevant risk control measures

Image quality performance testing was conducted with a compatible flat panel detector integrated with the system under defined exposure conditions and standardized methods.

Performance validation was conducted using the final production configuration of the DRE Duo system, including total filtration of 2.9 mm Al equivalent.

The testing included objective image quality metrics such as MTF and DQE.

The results demonstrate that the subject device performs as intended and that any differences from the predicate device do not raise new questions of safety or effectiveness.

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510(k) number: K260482---

## **10. Non-clinical test summary**

No clinical testing was conducted for the DRE Duo Diagnostic X-ray System.

Clinical data were not required to support this submission because the device has a well-established intended use, operating principle, and technological characteristics.

The safety and effectiveness of such devices have been demonstrated through non-clinical performance testing, recognized standards, and comparison with legally marketed predicate devices under product code KPR.

No new questions of safety or effectiveness are raised

## **11. Summary**

Based on the performance data as documented in the above testing, the DRE Duo with Radiography is found to have a safety and effectiveness profile that is similar to the predicate device.

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