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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek ViZion + DR device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K123644) does not outline specific numerical acceptance criteria for image quality metrics. Instead, it relies on a qualitative assessment for substantial equivalence.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Clinical Image Quality	As safe and effective as the predicate devices (Viztek ViZion DR, K112661, and Atlaim ATAL 8, K113812), specifically, image quality should be "equal or better" than the predicates.	"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."
Electrical Safety	Compliance with IEC 60601-1 (for electrical safety) and IEC 60601-1-2 (for EMC).	"Electrical Safety per IEC-60601-1 and EMC per IEC 60601-1-2."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	"Electrical Safety per IEC-60601-1 and EMC per IEC 60601-1-2."
MTF and DQE	No explicit criteria mentioned, but assumed to be comparable to or better than predicate devices, as these are standard metrics for digital imaging systems.	"MTF and DQE measurements... was conducted in accordance with FDA guidance documents." (Results not explicitly provided in the summary, but implied to be acceptable for substantial equivalence).
Risk Analysis	Compliance with FDA guidance documents.	"Risk Analysis... was conducted in accordance with FDA guidance documents."
Software Validation	Compliance with FDA guidance documents.	"Software validation was conducted in accordance with FDA guidance documents."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical images were acquired," implying a set of images, but the exact number is not provided.
Data Provenance: The document does not specify the country of origin of the data. It is implied to be retrospective or a limited prospective acquisition for the purpose of the 510(k) submission, as it involves comparison to existing predicate devices. The study is described as a clinical image evaluation, not a large-scale clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: "a board certified radiologist" (singular).
Qualifications: "board certified radiologist." No further details on years of experience are provided.

4. Adjudication Method for the Test Set

Adjudication Method: "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." This indicates a single reader assessment, not a multi-reader adjudication method (like 2+1 or 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation was performed by a single board-certified radiologist.
Effect Size: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a digital flat panel X-ray detector system, not an AI algorithm. Therefore, a standalone performance study in the context of an AI algorithm is not applicable. The device itself is the imaging system, and its performance is assessed directly (both technically and clinically).

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical image evaluation was expert opinion/consensus, specifically the judgment of a single board-certified radiologist comparing the new panel's images to those from predicate panels. There is no mention of pathology or outcomes data for establishing ground truth in this submission.

8. The Sample Size for the Training Set

This submission describes a hardware modification (a new digital panel combined with existing software) and its equivalence to predicate devices, not the development or training of a new AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

Summary

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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
1. Equivalent legally marketed device: Viztek ViZion DR, K112661 and Atlaim ATAL 8, K113812.
1. 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.
1. 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.
1. 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.

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6. Substantial Equivalence Chart

Characteristic	Viztek ViZion DR	Atlaim ATAL 8, K113812.	Viztek ViZion + DR
	K112661
Intended Use:	ViZion DR is intended fordigital image capture use ingeneral radiographicexaminations, whereverconventional screen-filmsystems may be used,excluding fluoroscopy,angiography andmammography. ViZionallows imaging of the skull,chest, shoulders, spine,abdomen, pelvis, andextremities.	The ATAL 8 and ATAL8c is indicated for use 'ingeneral radiographicimages of human anatomy.It is intended to replaceradiographic film/screensystems in all general-purpose diagnosticprocedures,excluding fluoroscopic,angiographic, andmammographicapplications	ViZion + DR is intendedfor digital image captureuse in general radiographicexaminations, whereverconventional screen-filmsystems may be used,excluding fluoroscopy,angiography andmammography. ViZion +allows imaging of theskull, chest, shoulders,spine, abdomen, pelvis,and extremities.
Configuration	This submission is for theDigital Panel and Softwareonly, no generator or standprovided.	This submission is for theDigital Panel and Softwareonly, no generator or standprovided.	This submission is for theDigital Panel and Softwareonly, no generator or standprovided.
Digital Panel	Samsung LTX240AA01-A(K090742)Pixel size 143 μm3072 x 3072 pixels 9million pixels.	Pixel size 139 μm3072 X 3072 pixels (9million pixels	iRay Technology(Shanghai) Ltd.For the 17" x 17" panel:Pixel size 139 μm3064×3072 pixels (9million pixels)For the 14" x 17" panel:Pixel size 150 μm2288×2800 pixels (6.4million pixels)
Software	Employs OPAL-RADPACS image viewing andacquire interface softwaretechnology, K063337	The Atal-8 can be usedwith any FDA-cleared off-the-shelf radiographicimage acquisition softwarepackage that outputs asuitable DICOM imagelike OmniVision softwareby OmniVision, clearedunder K110040.	SAME as K112661, outputs a DICOM image.
DICOM	Yes	Option	Yes
Power source	AC Line	AC Line	AC Line
Electricalsafety andEMC	Electrical Safety per IEC-60601. UL listed	Electrical Safety per IEC60601-1 and EMC per IEC60601-1-2.	Electrical Safety per IEC60601-1 and EMC per IEC60601-1-2.

1. 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. .

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1. 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.
1. 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.

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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

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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

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Indications for Use 510(k) Number (if known): K12:3644

Device Name: ViZion + DR, Digital Flat Panel X-Ray Detector System

Indications For Use:

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 .

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.