Televere Digital Imaging System

K170975 · Televere Systems · MQB · May 1, 2017 · Radiology

Device Facts

• Record ID: K170975
• Device Name: Televere Digital Imaging System
• Applicant: Televere Systems
• Product Code: MQB · Radiology
• Decision Date: May 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Not for mammography.

Device Story

Televere Digital Imaging System captures digital X-ray images for general radiography. System comprises PerkinElmer XRpad 4343F-N flat panel detector (FPD), PC-based computer, power supply, and TigerView Professional software. FPD uses amorphous silicon sensor array with gadolinium oxysulfide (GadOx) scintillator to convert X-rays to digital signals. Software manages image acquisition, display, editing (resize, contrast, crop), storage, printing, and distribution within PACS environment. Used in clinical settings by trained personnel; integrates with high-frequency X-ray generators via interface power unit or automatic exposure detection (AED). Provides high-quality images for physician review to support clinical decision-making. Benefits include digital workflow efficiency and diagnostic image quality comparable to or better than predicate systems.

Clinical Evidence

Bench testing included electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2) compliance. Performance testing followed FDA guidance for solid-state digital X-ray panels, including MTF and DQE measurements. Clinical images were provided for inspection but were not required to establish substantial equivalence. No clinical trials were conducted.

Technological Characteristics

Amorphous silicon sensor array with GadOx scintillator; 4318 x 4320 pixel matrix; 100 µm pixel pitch; 16-bit A/D conversion. Connectivity via Gigabit Ethernet. Power: 100-240 Vac. Dimensions: 460 x 460 x 15 mm. Software: TigerView Professional (PACS). Standards: IEC 60601-1, IEC 60601-1-2, UL Listed.

Indications for Use

Indicated for digital radiographic imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities in patients requiring general radiographic examinations. Not indicated for mammography.

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

• ViZion + DR, Digital Flat Panel X-Ray Detector System (K123644)

Reference Devices

• TigerView Professional (K061035)
• XRpad 4343F MED Flat Panel Detector (K142698)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 1, 2017

Televere Systems % Robert Bakin Regulatory Consultant Technology & Business Law Advisors, LLC 1244 Capuchino Avenue Burlingame, California 94010

Re: K170975

Trade/Device Name: Televere Digital Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: March 21, 2017 Received: April 3, 2017

Dear Robert Bakin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michal D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170975

Device Name Televere Digital Imaging System

#### Indications for Use (Describe)

The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, pelvis, and extremities. Not for mammography.

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

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### 510(k) Summary 510(k) Number K170975

Image /page/3/Picture/1 description: The image shows the logo for TELEVERE SYSTEMS. The word "TELEVERE" is in orange, and the word "SYSTEMS" is in gray. To the right of the logo are the words "ACQUIRE, STORE, VIEW, SHARE" in gray.

Televere Systems, LLC 1160 Cavalier Road Arnold, MD 21012 Email: [e-mail] Establishment Registration Number: 2954358 Phone: [phone] CONTACT: Robert E. Bakin Email: [e-mail] Technology & Business Law Advisors, LLC

1244 Capuchino Avenue, Burlingame, CA 94010 Prepared April 26, 2017

## 1. Identification of the Device:

Proprietary-Trade Name: Televere Digital Imaging System Classification Name: Stationary X-ray System Product Code MQB, Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680

- 2. Equivalent legally marketed device: ViZion + DR, Digital Flat Panel X-Ray Detector System K123644 Classification Name: Stationary X-ray System Product Code MQB, Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680
## 3. Associated legally marketed devices:

The Software, TigerView Professional (PACS Software) K061035. This is the software used with this device.

Classification Name: System, Image Processing, Radiological, Code LLZ Common/Usual Name: Picture Archiving and Communications System Device Class/Regulation Number: Class II per regulation 892.2050. Similar Flat Panel Detector: XRpad 4343F MED Flat Panel Detector, K142698 Product Code MQB Classification Name: Stationary X-ray System Common/Usual Name: Digital X-Ray Receptor Panel Device Class/Regulation Number: Class II per regulation 892.1680

- 4. Indications for Use (intended use) The Televere Digital Imaging System is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used. Allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Not for mammography.

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- 5. Description of the Device: The Televere Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer and a power supply. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional). This previously cleared software provides basic image adjustment features: An image management system that allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PCcompatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (PerkinElmer Model XRPad 4343F N) has not been previously cleared by FDA. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination.
Integration-level requirements/restrictions: This device will work with most modern highfrequency X-ray generators currently on the market. Sync with the generator is achieved through the interface power unit, supplied. Alternately the panel has automatic exposure detection (AED). If this mode is used, the precautions listed in the panel user manual must be observed. The user should confirm that the generator/tubestand combination proposed employs only Electronic Product Radiation Control certified components. The user should use only trained service engineers during the integration process and fully test the system prior to use on patients.

- 6. Safety and Effectiveness, comparison to predicate device. The results of clinical image inspection, bench, and test laboratory results indicates that the new device is as safe and effective as the predicate device. Clinical images collected demonstrate equal or better image quality as compared to our predicate.

| | Viztec LLC: ViZion + DR, Digital Flat Panel X-Ray<br>Detector System K123644 | Televere Digital Imaging System K162521<br>Using XRpad 4343F-N panel |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | ViZion + DR is intended for digital image<br>capture use in general radiographic<br>examinations, wherever conventional screen-<br>film systems may be used, excluding<br>fluoroscopy, angiography and mammography.<br>ViZion + allows imaging of the skull, chest,<br>shoulders, spine, abdomen, pelvis, and<br>extremities. | The Televere Digital Imaging System is<br>intended for digital image capture use in<br>general radiographic examinations,<br>wherever conventional screen-film systems<br>may be used. Allows imaging of the skull,<br>chest, shoulders, spine, abdomen, pelvis,<br>and extremities. Not for mammography.<br>(Essentially identical) |
| Configuration | Digital Panel and Software only, no generator<br>or stand provided. | SAME |
| Digital Panel | 3072×3072 pixels with 139µm pitch | 4318 × 4320 100 µm Pixel Pitch. Better<br>Resolution |
| Internal<br>image storage | 200 images | 1 GB DDR3, 4 GB SDHC card, number of<br>images depends on image size. Example for<br>10 mb image there would be room for 500<br>images. |

## 7. Substantial Equivalence Chart

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| | Viztec LLC: ViZion + DR, Digital Flat Panel X-Ray<br>Detector System K123644 | Televere Digital Imaging System K162521<br>Using XRpad 4343F-N panel |
|---------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Image<br>acquisition<br>time | ≤ 5 Seconds | SAME |
| DICOM 3 | YES | YES via our software cleared in K061035 |
| A/D<br>Conversion | 12 Bit | 16 Bit |
| Scintillator | Gadolinium Oxysulfide (GadOx) | Gadolinium Oxysulfide (GadOx) |
| MTF | 54% (1 cy/mm), 23% (2 cy/mm) (not measured<br>at 4 cy/mm) for RQA5 | 55% (1 cy/mm), 25% (2 cy/mm) 5% (4<br>cy/mm) for RQA5. Better than predicate |
| DQE | 30% (0 cy/mm), 18% (1 cy/mm), 3% (3 cy/mm)<br>for RQA5. | 40% (0 cy/mm), 30% (1 cy/mm), 10% (3<br>cy/mm) for RQA5. Better than predicate |
| Interface | Gigabit Ethernet Port | SAME |
| Panel<br>Dimensions | 495 (w) x 510 (l) x 38 mm (h) | 460 mm (w) × 460 mm (l) × 15 mm (h) |
| Power Source | External Power Supply 100-240 Vac | SAME |
| Electrical<br>safety and<br>EMC | Electrical Safety per IEC 60601-1 and EMC per<br>IEC 60601-1-2. UL Listed | SAME |

The comparison table reveals there are no new issues of safety or effectiveness raised by the modification to the scintillator of the digital x-ray panel.

- 7. Summary of Bench Testing Conducted: IEC Standards have been employed for: Electrical Safety and Electromagnetic Compatibility. The panel power supply is UL Listed. We compared MTF and DQE measurements for the original and modified scintillator versions of the panel and found them to be similar enough not to make a notable difference in acquired images. As compared to the predicate panel the MTF and DQE performance of the new panel is superior. The digital panel manufacturer conducted performance testing according to the FDA guidance document for solid state digital x-ray panels. Risk Analysis and System operation verification tests were conducted in accordance with FDA guidance documents. Since no software modifications were required, confirmation testing was performed. Labeling was developed to comply with the FDA solid state panel guidance document.
- 8. Summary of Clinical Testing: Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence.
- 9. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Televere that the Televere Digital Imaging System K162521 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The new and predicate devices provide values for MTF and DQE that are substantially equivalent.