VIZION DR by VIZTEK, INC. | FDA 510(k) Summary

ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediattic, 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 intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the 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 Samsung FPD were not changed.

AI/ML Overview

The provided text is a 510(k) summary for the Viztek ViZion DR, a digital flat panel X-Ray detector system. It describes the device, its intended use, and states that bench and test laboratory results indicate the new device is as safe and effective as predicate devices, with clinical images demonstrating equal or better image quality.

However, the document does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, information about expert involvement, adjudication methods, or MRMC study details. The 510(k) summary is a high-level comparison to predicate devices, focusing on substantial equivalence rather than a detailed performance study with quantifiable acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the text provided:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Clinical images demonstrate equal or better image quality as compared to predicate devices.
Not specified in document	Device is as safe and effective as predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified. The document only states "Clinical images collected."
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from which country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document does not mention the involvement of experts in establishing ground truth or evaluating the clinical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified. No adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not specified. The document does not mention an MRMC study or any AI assistance. The device is a digital X-ray detector system, not an AI-powered analysis tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not specified. The device is a digital X-ray detector system, not an algorithm, so the concept of "standalone" performance for an algorithm isn't directly relevant in the context of this document. The document focuses on the image quality produced by the detector.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. The document only states "Clinical images collected demonstrate equal or better image quality." It does not elaborate on how "image quality" was objectively assessed or against what ground truth.

8. The sample size for the training set

Not applicable/Not specified. This device is an imaging hardware system. It does not appear to involve machine learning models that would require a "training set" in the conventional sense. The "training" here would refer to engineering and calibration, not data-driven model training.

9. How the ground truth for the training set was established

Not applicable/Not specified. (See point 8).

Summary

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510(k) Number K102123 Viztek, Inc. 6491 Powers Avenue Jacksonville. FL 32217 Phone: 800.366.5343 Fax: 904.448.9936 Date Prepared: July 21, 2010 Contact: Bruce Ashby, Sales and Marketing Manager 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

510(k) Summarv

Equivalent legally marketed device: Viztek DR, K082604 and Viztek Opal-RAD™ K063337. This new device employs the identical digital panel described in K090742, the Samsung Digital Flat Panel
Indications for Use (intended use) ViZion DR is intended for digital image capture use in general radiographic examinations for Adult and Pediatric 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.
Description of the Device: The ViZion DR system represents the straightforward intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary

OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the 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 Samsung FPD were not changed.

Safety and Effectiveness, comparison to predicate device. The results of bench and test laboratory 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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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, uppercase letters. To the left of the text is a symbol that is part of the department's official branding.

Public Health Service

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

Viztek, LLC % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

AUG 23 2013

Re: K102123

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: KPR and MOB Dated: October 8, 2010 Received: October 14, 2010

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of January 24, 2011,

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mental device-leated adverse overity systems (QS) regulation (21 CFR Part 820). This letter requirements as be form in are quarte as described in your Section 510(k) premarket wnifanow you to oogin finding of substantial equivalence of your device to a legally marketed nonication. The FDF imany of Scation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise not 1000 1200 1000 1000 1000 100 100 100 100 100 100 100 100 100 100 100 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 Tou may 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K10 ZI 23

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 CDHR, Office of In Vitro Diagnostic Devices (OVID)

Andel D'Hun

n of Radiological Office of In

510K K102123

Page I of I

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.