VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS by VIDAR SYSTEMS CORP.

Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.

Device Description

The VIDAR VISION 3000 Digital Radiography system is an affordable DR (Digital Radiographic) solution designed for smaller radiography environments, including imaging centers, orthopedic practices, small hospitals, and outpatient areas of hospitals. The VIDAR VISION 3000 is the first truly affordable, full-featured DR system. providing a total solution for all digital radiographic examinations. The VIDAR VISION 3000 features high image quality, rapid image acquisition, improved productivity, and ease of use. The flexible system features a 3K detector for the high-resolution imaging needs of busy radiology centers, orthopedic practices, and hospitals. VIDAR's new VISION DR product line also includes the VISION 4000 system, with a 4K detector that is ideal for higher volume settings.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative manner. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not available in the provided document.

However, based on the provided text, we can infer some details related to the evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly related to demonstrating "substantial equivalence" to the predicate device, meaning the new device is as safe and effective and has no new indications for use. The performance is reported in terms of functional equivalence and technological specifications.

Characteristic	Acceptance Criteria (Implied by Predicate Device K042876)	Reported Device Performance (Vidar Vision 3000/4000)
Intended Use	General purpose diagnostic X-ray unit	SAME (General purpose diagnostic X-ray unit, not for mammography)
Safety and Effectiveness	As safe and effective as predicate	"The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." (Conclusion)
User Interface	Depends on Control console option, mainly dedicated touch controls	Software Driven Touch Panel LCD, + remote control unit + remote console
Maximum Output	30 kW to 64 kW	50, 64, and 80 kW
Image Acquisition	Digital: CANON CXDI-50G (K031447)	Digital: Vidar Digital Radiographic Detector (K070563)
Digital Panel Size	Up to 14" x 17" active area	Vision 3000/4000: Active image size: 16 x 16 inches (40cm x 40cm)
Digital Resolution	160 x 160 microns pixel pitch, approx. 6 million pixels	Vision 3000: 160 Micron, 3056 x 3056 (9 megapixels)Vision 4000: 120 Micron, 4096 x 4096 (16 megapixels)
Method of Control	Dedicated push button Controls	Software Driven Touch Panel LCD
Collimator	Manual R302/A	Balco B302I/A DHHS

2. Sample size used for the test set and the data provenance

The document states "bench, user, and standards testing" were conducted. However, no specific sample sizes or details about data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The testing appears to be primarily focused on technical specifications and functionality as compared to the predicate device, rather than diagnostic accuracy against a ground truth assessed by experts.

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

Not applicable/Not provided. As there's no mention of expert evaluation of diagnostic images for ground truth, adjudication methods are not relevant here.

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 applicable. This device is an X-ray system, not an AI-powered diagnostic tool. Thus, MRMC studies and AI-assisted improvements are not relevant.

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

Not applicable. This device is an X-ray system, not an algorithm. Standalone algorithm performance is not relevant.

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

Not applicable/Not provided. The "ground truth" in this context is the performance and safety established for the predicate device, against which the new device's technical specifications and functional capabilities are compared. This is a comparison of device characteristics, not a diagnostic accuracy study requiring a clinical ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is a hardware device (X-ray system), not an algorithm that requires a training set.

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

Not applicable/Not provided. As above, this is a hardware device.

Summary

{0}------------------------------------------------

K071193

MAY 3 0 2007

Image /page/0/Picture/2 description: This image shows the letterhead for VIDAR systems corporation. The letterhead includes the company logo, address (365 Herndon Parkway, Herndon, VA 20170), phone numbers (800.471.7226, +1.703.471.7070), and fax number (+1.703.471.7665). The contact person is Carrie L. Brancart, Quality Manager, and the date prepared is May 13, 2007.

-1

1. Identification of the Device: Proprietary-Trade Name: Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems Classification Name: Stationary X-ray system, Product Codes Product Code 90 KPR and MQB Common/Usual Name: General purpose diagnostic X-ray Unit.
1. Equivalent legally marketed devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL Universal Radiographic Systems K012546 AND the Vidar 2000 Digital Radiographic Detector, K070563. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K042876 ..
1. Indications for Use (intended use) Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.
1. Description of the Device: The VIDAR VISION 3000 Digital Radiography system is an affordable DR (Digital Radiographic) solution designed for smaller radiography environments, including imaging centers, orthopedic practices, small hospitals, and outpatient areas of hospitals. The VIDAR VISION 3000 is the first truly affordable, full-featured DR system. providing a total solution for all digital radiographic examinations. The VIDAR VISION 3000 features high image quality, rapid image acquisition, improved productivity, and ease of use. The flexible system features a 3K detector for the high-resolution imaging needs of busy radiology centers, orthopedic practices, and hospitals. VIDAR's new VISION DR product line also includes the VISION 4000 system, with a 4K detector that is ideal for higher volume settings.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.

{1}------------------------------------------------

1. Substantial Equivalence Chart, Vidar Vision 3000 and Vidar Vision 4000
  :

Characteristic	Sedecal URS X-RayUnits with DigitalDetectorK042876	Vidar Vision 3000and Vidar Vision4000Combines twocleared devices:K070563 ANDK012546
Intended Use:	General purposediagnostic X-ray unit	SAME
User Interface	Depends on ControlConsole option chosen.Mainly dedicated touchcontrols	Software Driven TouchPanel LCD, + remotecontrol unit + remoteconsole
Maximum output	Depends on model ofgenerator chosen.Models available from30 kW to 64 kW	50, 64, and 80 kW
Image Acquisition	Digital: CANONCXDI-50G.K031447	Digital: Vidar DigitalRadiographic DetectorK070563
Digital Panel Size	Up to 14" x 17" activearea	Vision 3000/4000:Active image size: 16 x16 inches (40cm x 40cm)
Digital Resolution	160 x 160 micronspixel pitch, withapproximately 6million pixels	Vision 3000:160 Micron.3056 x 3056 (9megapixels)Vision 4000:120 Micron4096 x 4096 (16megapixels)
Method of Control	Dedicated push buttonControls	Software Driven TouchPanel LCD
Collimator	Manual R302/A	Balco B302I/A DHHS

Conclusion After analyzing bench, user, and standards testing data, it is the conclusion of Vidar Systems that the Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are as safe and effective as the predicate devices, have tew technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes a symbol with three blue lines and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The symbol is on the left side of the text.

Public Health Service

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

Vidar Systems Corporation % Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

AUG 2 3 2013

Re: K071193

Trade/Device Name: Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 24. 2007 Received: April 30, 2007

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of May 30, 2007.

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

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K071193

Device Name: Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems

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 Device Evaluation (ODE)

Hul
(Division Sigh-Off)
Division of Reproductive, Abdominal, and

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page I 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.