Who is the manufacturer of VIZION + DR?

Viztek, LLC filed the 510(k) submission for VIZION + DR (K123644).

What is the FDA product code for VIZION + DR?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for VIZION + DR?

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

What are the predicate devices for VIZION + DR?

Viztek ViZion DR (K112661); Atlaim ATAL 8 (K113812).

Who can help prepare an FDA 510(k) submission like VIZION + DR?

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.

VIZION + DR

K123644 · Viztek, LLC · MQB · Jan 11, 2013 · Radiology

Device Facts

Record ID	K123644
Device Name	VIZION + DR
Applicant	Viztek, LLC
Product Code	MQB · Radiology
Decision Date	Jan 11, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

Device Story

ViZion + DR is a digital radiography system consisting of a flat panel digital detector (FPD) and image acquisition software. It captures X-ray signals to produce digital radiographic images, replacing conventional film-screen systems. The device is used in clinical settings by healthcare professionals to perform general radiographic examinations. The system integrates with PACS for image viewing and storage. The output is a DICOM-compliant digital image, which clinicians use to support diagnostic decision-making. The device benefits patients by providing the advantages of digital radiography, such as improved workflow and filmless environment, while maintaining image quality comparable to or better than previous systems.

Clinical Evidence

Clinical evaluation consisted of a qualitative assessment of clinical images by a board-certified radiologist. The study compared images acquired with the new panel against those from the predicate panel. The radiologist concluded that the image quality of the ViZion + DR was as good as or better than the predicate device.

Technological Characteristics

Digital flat panel X-ray detector system. Available in 14" x 17" and 17" x 17" sizes. Pixel sizes: 139 μm (17"x17") and 150 μm (14"x17"). Connectivity: DICOM output. Power: AC line. Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Software: OPAL-RAD PACS interface.

Indications for Use

Indicated for general radiographic imaging of human anatomy, including skull, chest, shoulders, spine, abdomen, pelvis, and extremities, as a replacement for conventional screen-film systems. Contraindicated for fluoroscopy, angiography, and 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

Viztek ViZion DR (K112661)
Atlaim ATAL 8 (K113812)

Reference Devices

OmniVision software (K110040)
OPAL-RAD PACS (K063337)

Related Devices

K112661 — VIZION DR · Viztek, LLC · Oct 20, 2011
K102123 — VIZION DR · Viztek, Inc. · Jan 24, 2011
K133139 — VIZION ULTRA · Viztek, LLC · Apr 3, 2014
K113449 — FUSION FLAT PANEL · Icrco, Inc. · Jun 14, 2012
K160810 — ViZion DR + Wireless · Viztek, LLC · May 20, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ ### 510(k) Summary 510(k) Number K12 364 Y JAN 1 1 2013 #### Viztek, LLC. 6491 Powers Avenue Jacksonville, FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: November 9, 2012 Bruce Ashby, Sales and Marketing Manager Contact: - 1. Identification of the Device: Proprietary-Trade Name: ViZion + DR Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) 90 MQB, Common/Usual Name: Digital X-Ray Receptor Panel - 2. Equivalent legally marketed device: Viztek ViZion DR, K112661 and Atlaim ATAL 8, K113812. - 3. Indications for Use (intended use) ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. - 4. Description of the Device: The ViZion + DR system represents the straightforward integration of a new digital x-ray receptor panel and our previously cleared software. This is a MODIFICATION of our clearance K112661 wherein we have changed the supplier of the panel. - ViZion + DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) ViZion + is designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and the new receptor panel were not changed. Our main predicate is ViZion DR, K112661, wherein we combined our OPAL-RAD software with a new digital panel. We now also offer two sizes of panels: 14" x 17" and 17" x 17" panels. - 5. 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 devices. Clinical images collected demonstrate equal or better image quality as compared to our predicates. {1}------------------------------------------------ ## 6. Substantial Equivalence Chart | Characteristic | Viztek ViZion DR | Atlaim ATAL 8, K113812. | Viztek ViZion + DR | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K112661 | | | | Intended Use: | ViZion DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | The ATAL 8 and ATAL 8c is indicated for use 'in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general- purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications | ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. | | Configuration | This submission is for the Digital Panel and Software only, no generator or stand provided. | This submission is for the Digital Panel and Software only, no generator or stand provided. | This submission is for the Digital Panel and Software only, no generator or stand provided. | | Digital Panel | Samsung LTX240AA01-A (K090742) Pixel size 143 μm 3072 x 3072 pixels 9 million pixels. | Pixel size 139 μm 3072 X 3072 pixels (9 million pixels | iRay Technology (Shanghai) Ltd. For the 17" x 17" panel: Pixel size 139 μm 3064×3072 pixels (9 million pixels) For the 14" x 17" panel: Pixel size 150 μm 2288×2800 pixels (6.4 million pixels) | | Software | Employs OPAL-RAD PACS image viewing and acquire interface software technology, K063337 | The Atal-8 can be used with any FDA-cleared off- the-shelf radiographic image acquisition software package that outputs a suitable DICOM image like OmniVision software by OmniVision, cleared under K110040. | SAME as K112661, outputs a DICOM image. | | DICOM | Yes | Option | Yes | | Power source | AC Line | AC Line | AC Line | | Electrical safety and EMC | Electrical Safety per IEC- 60601. UL listed | Electrical Safety per IEC 60601-1 and EMC per IEC 60601-1-2. | Electrical Safety per IEC 60601-1 and EMC per IEC 60601-1-2. | - 7. Summary of Bench Testing Conducted: IEC Standards were employed for: Electrical Safety and Electromagnetic Compatibility. MTF and DQE measurements, Risk Analysis and Software validation was conducted in accordance with FDA guidance documents. . {2}------------------------------------------------ - 8. Summary of Clinical Testing: Clinical images were acquired and evaluated by a board certified radiologist who concluded the images from the new panel are as good as or better than the images acquired with the predicate panel. - 9. Conclusion: After analyzing bench, clinical image, and external laboratory testing to applicable standards, it is the conclusion of Viztek Inc that the Viztek ViZion + DR is as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 January 11, 2013 Viztek LLC % Mr. Daniel Kamm, P.E. Principal Engineer Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114 Re: K123644 Trade/Device Name: ViZion + DR. Digital Flat Panel X-Ray Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-ray System Regulatory Class: II Product Code: MQB Dated: November 15, 2012 Received: November 28, 2012 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. 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 {4}------------------------------------------------ Page 2-Mr. Kamm device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, # Sean M. Boyd -S Janine M. Morris · Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Indications for Use 510(k) Number (if known): K12:3644 Device Name: ViZion + DR, Digital Flat Panel X-Ray Detector System #### Indications For Use: ViZion + DR is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion + allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Sean M.Boyd -S. (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological 51000 K123644 Page 1 of 1 .