E-COM DR-2000 DR

K193644 · Livermoretech, Inc. · MQB · Feb 14, 2020 · Radiology

Device Facts

• Record ID: K193644
• Device Name: E-COM DR-2000 DR
• Applicant: Livermoretech, Inc.
• Product Code: MQB · Radiology
• Decision Date: Feb 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.

Device Story

E-COM DR-2000 DR is a Windows 10-based software system designed to upgrade film-based X-ray systems to digital. It interfaces with FDA-cleared digital X-ray receptor panels to acquire, process, and manage diagnostic images. Operated by qualified medical personnel in clinical settings, the software manages patient registration, procedure selection, technique adjustment, image preview/QC, and image stitching. It supports transfer of images to hardcopy, softcopy, and archive devices via network. The system facilitates clinical decision-making by providing high-quality digital images for review, history tracking, and re-examination. Benefits include improved workflow efficiency, digital archiving, and the ability to integrate with various X-ray detectors and generators.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including software validation and risk analysis conducted in accordance with FDA guidance and IEC 14971 standards.

Technological Characteristics

Windows 10-based software for digital X-ray image acquisition. Compatible with various FDA-cleared digital X-ray receptor panels (Toshiba, Thales, Varian) and generators (Sedecal, CPI, Siemens, Del). Connectivity via DICOM 3.0. Software is a moderate level of concern device.

Indications for Use

Indicated for digital image capture in general radiographic examinations (skull, chest, shoulders, spine, abdomen, pelvis, extremities) where conventional screen-film systems are used. Excludes fluoroscopy, angiography, and mammography. For use by qualified medical personnel.

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

• Sedecal Digital Radiographic Upgrade Model SDRU-T (K130883)

Reference Devices

• Toshiba FDX4343R Detector (K130883)
• Toshiba FDX3543RP Detector (K130883)
• Toshiba FDX3543RPW Detector (K171353)
• Toshiba FDX2530RPW Detector (K162687)
• Toshiba FDX4343RPW Detector (K162687)
• Thales Pixium RAD 4143 Detector (K133139)
• Thales Pixium RAD 4343 Detector (K133139)
• Thales Pixium RAD 3543 Detector (K141440)
• Thales Pixium RAD 3543EZ Detector (K141440)
• Thales Pixium RAD 2430EZ Detector (K141440)
• Thales Pixium RAD 3543DR Detector (K191813)
• Varian PaxScan 4336R Detector (K172007)
• Varian PaxScan 4343R Detector (K172007)
• Varian PaxScan 4336X Detector (K172007)
• Varian PaxScan 4336W Detector (K172007)

Submission Summary (Full Text)

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February 14, 2020

Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

LiverMoreTech, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

# Re: K193644

Trade/Device Name: E-COM DR-2000 DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 24, 2019 Received: December 30, 2019

Dear Mr. Kamm:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K193644

Device Name E-COM DR-2000 DR

#### Indications for Use (Describe)

Intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the physician, procedures would be contrary to the best interest of the patient.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
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| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Exhibit 5 510(k) Summary K193644 LiverMoreTech, Inc. 801 North Jupiter Rd, Suite 200, Plano, TX 75074, USA • TEL: [phone] • FAX: [phone] Date Prepared: January 22, 2020 Contact: Jay Kim, Development Manager

- 1. Identification of the Device: Trade/Device Name: E-COM DR-2000 DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB.
- 2. Predicate device: K130883 Trade/Device Name: Sedecal Digital Radiographic Upgrade Model SDRU-T Manufacturer: Sedecal SA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB.
- 3. Description of the Device: This is a Windows 10 based software to be used in conjunction with an FDA cleared digital x-ray receptor panel. It can be used to upgrade film-based systems. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the E-COM DR-2000 DR software:
- a. Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images.
- b. Edit existing patient information.
- Emergency registration and edit Emergency settings. C.
- d. Pick from a selection of procedures, which defines the series of images to be taken.
- e. Adjust technique settings before capturing the X-ray image.
- f. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations.
- g. Save an incomplete procedure, for which the rest of the exposures will be made at a later time.
- h. Close a procedure when all images have been captured.
- i. Review History images, resend and reprint images.
- Re-exam a completed patient. j.
- k. Protect patient records from being deleted by the system.
- Delete an examined Study with all images being captured. .
- m. Edit user accounts.
- n. Check statistical information.
- o. Image QC.
- p. Image stitching.

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- 4. Indications for Use: Intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
- 5. Technological Characteristics: This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. Specifications are for all intents and purposes identical. This submission represents the combination of two cleared devices: Software, and Digital X-Ray panel(s). The software is an updated version of the software supplied in the predicate device K130883 and is now compatible with more FDA cleared digital panels.

| | | 6. Comparison Table | |
|--|--|---------------------|--|
|--|--|---------------------|--|

| Characteristic | Predicate Device K130883<br>Sedecal Digital Radiographic Upgrade<br>Model SDRU-T | Proposed New Device E-COM DR-2000<br>DR |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Sedecal Digital Radiographic Upgrade<br>Model SDRU-T is intended for digital<br>image capture use in general radiographic<br>examinations, wherever conventional<br>screenfilm systems may be used,<br>excluding fluoroscopy. angiography and<br>mammography. The kit allows imaging of<br>the skull, chest, shoulders, spine.<br>abdomen, pelvis. and extremities. | Intended for digital image capture use<br>in general radiographic examinations,<br>wherever conventional screen-film<br>systems may be used, excluding<br>fluoroscopy, angiography and<br>mammography. The kit allows imaging<br>of the skull, chest, shoulders, spine,<br>abdomen, pelvis, and extremities.<br>(Identical) |
| Platform | Windows 7, 8, and 10 | Windows 10. Older Windows versions<br>are no longer supported by Microsoft |
| Compatible<br>Digital X-Ray<br>Receptor Panel(s) | Toshiba FDX4343R or FDX3543RP | Toshiba FDX4343R Detector<br>Toshiba FDX3543RP Detector<br>Toshiba FDX3543RPW Detector<br>Toshiba FDX2530RPW Detector<br>Toshiba FDX4343RPW Detector<br>Thales Pixium RAD 4143 Detector<br>Thales Pixium RAD 4343 Detector<br>Thales Pixium RAD 3543 Detector<br>Thales Pixium RAD 3543EZ Detector<br>Thales Pixium RAD 2430EZ Detector<br>Thales Pixium RAD 3543DR Detector<br>Varian PaxScan 4336R Detector<br>Varian PaxScan 4343R Detector<br>Varian PaxScan 4336X Detector<br>Varian PaxScan 4336W Detector |
| Compatible<br>Generator(s) | Sedecal | Sedecal, CPI, Siemens, Del. |
| DICOM 3<br>Compatibility | YES | YES |

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## Panel Clearance Table

| Panel ID | FDA Clearance |
|------------------------------------|---------------|
| Toshiba FDX4343R Detector | K130883 |
| Toshiba FDX3543RP Detector | K130883 |
| Toshiba FDX3543RPW Detector | K171353 |
| Toshiba FDX2530RPW Detector | K162687 |
| Toshiba FDX4343RPW Detector | K162687 |
| Thales Pixium RAD 4143 Detector | K133139 |
| Thales Pixium RAD 4343 Detector | K133139 |
| Thales Pixium RAD 3543 Detector | K141440 |
| Thales Pixium RAD 3543EZ Detector | K141440 |
| Thales Pixium RAD 2430EZ Detector | K141440 |
| Thales Pixium RAD 3543DR Detector | K191813 |
| Varian PaxScan 4336R Detector | K172007 |
| Varian PaxScan 4343R Detector | K172007 |
| Varian PaxScan 4336X Detector | K172007 |
| Varian PaxScan 4336W Detector | K172007 |

- 7. Bench/Performance Testing: The results of bench testing (software validation and risk analysis for a moderate level of concern device) shows that this new device poses no new issues of safety or effectiveness, has essentially the same technological characteristics as the predicate, and is therefore substantially equivalent to the predicate device. Software and labeling was developed in accordance with the following FDA guidance documents: Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices; Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Risk management was conducted in accordance with IEC 14971, Application of Risk Management to Medical Devices. Pediatric use precautions have been added as a supplement to the User Manual.
- 8. Clinical Testing: Not required for a showing of substantial equivalence.
- 9. Conclusion: Based on comparison to the 510(k) summary of the predicate device, its technical characteristics, the indications for use, and the near identical characteristics of the two products, we conclude that the E-COM DR-2000 DR is substantially equivalent to the named predicate device.