Column to be mounted to the wall .
Motor-driven overhead assembly with controls for patient postioning, setting of . technique factors and radiographic projection geometry.
Cassette drvie system with flat cassette for 15 x 30 cm film .
X-ray tubehead, with DC power supply ●
Remote control box and handswitch ●
During a panoramic exposure, the x-ray tubehead and cassette holder move around the patient's head. The beam from the x-fay tabe is commans locks the radiation scattered from the patient. Patient positioning is simple, accurate and consistent by means of three postioning lasers, a bite guide and head stabilizers. During the exposure, the patient postioning lasers, a bitc guite and nead backless. All movements for the panoramic remains still with e tholorized components retater traiser traotors, which are microprocessor controlled.
Along wit the Standard Panoramic mode, the Orthoralix 8500 provides a special child Along with the Bandard Fanolania me adiation dosage to the child, and confining the image to the dentition.

AI/ML Overview

This is a 510(k) premarket notification for the Gendex Orthoralix 8500 Panoramic Dental X-ray System, which is a submission to the FDA demonstrating substantial equivalence to a predicate device. 510(k) submissions typically do not contain details of specific acceptance criteria and detailed study reports in the same way a PMA (Premarket Approval) submission would.

The document provides a general overview of the device and its intended use, focusing on demonstrating equivalence to predicate devices already on the market. Therefore, the specific information requested about acceptance criteria and detailed study methodology is largely not present within this 510(k) summary.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this 510(k) summary.
510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness, or that any differences do not raise new questions of safety and effectiveness and that the data submitted demonstrate the device is as safe and effective as the predicate device. Specific quantitative acceptance criteria for performance metrics (e.g., image resolution, dose levels) and detailed performance data against those criteria are not typically included or required in the public 510(k) summary document for this type of device.

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

Not available in this 510(k) summary.
There is no mention of a dedicated "test set" in the context of clinical or performance evaluation data. The submission relies on the established safety and effectiveness of the predicate devices.
Data provenance (e.g., country of origin, retrospective/prospective) is also not discussed, as there are no explicit studies being described in this summary to evaluate the device against specific performance metrics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not available.
Since no specific study involving expert-derived ground truth (e.g., for diagnostic accuracy) is described, information on experts or their qualifications is not provided.

4. Adjudication Method

Not applicable/Not available.
As there's no diagnostic accuracy study described, an adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned.
This type of study is more common for evaluating AI-driven diagnostic tools where the goal is to quantify the improvement in human reader performance with AI assistance. The Orthoralix 8500 is an X-ray system, not an AI diagnostic algorithm, and its 510(k) submission does not include such a study.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study is not applicable or mentioned.
This device is an X-ray imaging system, not a standalone algorithm. Its performance is inherent in its imaging capabilities and technical specifications, which are established through engineering design and testing (not explicitly detailed in this summary) and benchmarked against predicate devices.

7. Type of Ground Truth Used

Not applicable/Not available in this context.
For an X-ray system, "ground truth" might refer to phantoms or calibrated targets used during technical performance testing (e.g., for resolution, dose, geometry). However, no specific studies using such ground truth are detailed in this 510(k) summary. The submission primarily relies on the equivalency to predicate devices.

8. Sample Size for the Training Set

Not applicable/Not available.
This device is an X-ray system, not a machine learning or AI algorithm that requires a "training set" of data.

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

Not applicable/Not available.
As there is no training set mentioned, this information is not relevant.

In summary, this 510(k) summary for the Gendex Orthoralix 8500 Panoramic Dental X-ray System is a regulatory document focused on demonstrating substantial equivalence to pre-existing predicate devices. It does not contain the detailed study information, acceptance criteria, or performance metrics typically found in more comprehensive clinical trial reports or new technology evaluations. The FDA's acceptance of this 510(k) primarily signifies that the device is deemed as safe and effective as the predicate devices, based on its similar intended use, materials, design, operational characteristics, and functional features.

Summary

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K050255

Image /page/0/Picture/1 description: The image shows the word "GENDEX" in a bold, sans-serif font. The letters are all capitalized and black. The "E" and "X" are connected at the bottom, and there is a registered trademark symbol next to the "X". The background is white.

Gendex Dental Systems es Plaines, IL 60018-1884 847 640 4800 Tel 847 640 4970 Fax www.gendex.com

MAR 1 7 2035

510(k) Summary Statement for the Gendex Orthoralix 8500 Panoramic Dental X-ray System

General Information I.

Submitter:	Gendex Dental Systems901 West Oakton StreetDes Plaines, IL 60018
Telephone:	(847) 640-4800 – Company number(847) 640-4924 - Contact person
Fax:	(847) 640-4970
Contact Person:	John R. MillerDirector, Quality Assurance and Regulatory Affairs
Summary Preparation Date:	January 31, 2005

II. Names

Device Name:	Orthoralix 8500 Panoramic Dental X-ray System
Primary Classification Name:	90EHD - Extraoral Source X-ray System

III. Predicate Devices

Gendex Orthoralix 9200 .
. Planmeca DIMAX2
. Gendex Orthoralix 9200 DDE
Gendex GX-9000 .

IV. Product Description

The Orthoralix 8500 is a system for rotational panoramic radiography of the dentomaxillo-facial area. The system consists of:

Column to be mounted to the wall .
Motor-driven overhead assembly with controls for patient postioning, setting of . technique factors and radiographic projection geometry.
Cassette drvie system with flat cassette for 15 x 30 cm film .
X-ray tubehead, with DC power supply ●
Remote control box and handswitch ●

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

Image /page/1/Picture/0 description: The image shows the word "GENDEX" in a bold, sans-serif font. The letters are all capitalized and black. The "E" is slightly larger than the other letters. There is a registered trademark symbol to the right of the "X".

dex Dental Systems

During a panoramic exposure, the x-ray tubehead and cassette holder move around the During a panoramic exposure, the x-ray tube is collimated by a slit diaphragm. The flat patient's head. The beam from the x-fay tabe is commans locks the radiation scattered from the patient. Patient positioning is simple, accurate and consistent by means of three postioning lasers, a bite guide and head stabilizers. During the exposure, the patient postioning lasers, a bitc guite and nead backless. All movements for the panoramic remains still with e tholorized components retater traiser traotors, which are microprocessor controlled.

Along wit the Standard Panoramic mode, the Orthoralix 8500 provides a special child Along with the Bandard Fanolania me adiation dosage to the child, and confining the image to the dentition.

V. Indications for Use/Rationale for Substantial Equivalence

The Orthoralix 8500 Panoramic Dental X-ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

It share the same indications for use, similar materials, design, operational, and functional It share the same includio for act, equivalent to the predicate devices listed in Section II of this summary.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head. The seal appears to be a government emblem, likely representing the U.S. Department of Health and Human Services.

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Mr. John R. Miller IMI. John IC: Nince
Director, Quality Assurance & Regulatory Affairs Gendex Dental Systems 901 W. Oakton Street DES PLAINES IL 60018

Re: K050255

KU30233
Trade/Device Name: Orthoralix 8500 Panoramic Dental X-ray System Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: February 2, 2005 Received: February 3, 2005

Dear Mr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave revewed your becases by the promotially equivalent (for the indications for use stated in above and have decemined the do rest cate devices marketed in interstate commerce prior to the enclosure) to regarly manelocal Device Amendments, or to devices that have been May 20, 1970, dic Clacinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a prematic approval application (PMA). You may, therefore, market the do not require approval of a promation approvisions of the Act. The general controls provisions of the Act device, subject to the general oculess prior, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

MAR 1 7 2005

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is classified (300 a00 ro) into controls. Existing major regulations affecting your Apploval), it thay be subject to sach acerate Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be round minouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please of advisor mar PDT is issuation of levice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administrated to registration and listing (21 CFR Part 807); labeling ACL STEQuirements, moduling, but not a more a vertirements as set forth in the quality systems (QS) (21 CFR Fart 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the submit and the finding of unction of unction of your device to a le This letter will allow you to begin marketing your vice as usences an your device to a legally
premarket notification. The FDA innding of substantial equivales your device y premarket notification. The FDA inding of substantial equivalence of your device to
marketed predicate device results in a classification for your device and thus, permits y proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased If you desire specific advice for your device on our labeling regaration (1) virus and on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoranion on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsibility.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 DIVIsion of Sman Manakaland of at its Internet address 058-2041 01 (51 gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not Assigned

Device Name:

Orthoralix 8500 Panoramic Dental X-Ray System

Indications for Use:

The Orthoralix 8500 Panoramic Dental X-Ray System is to be used as an I he Orthoranx 8500 Fanoraline Delital Ar Bay 99
extraoral source of x-rays for imaging of the dento-maxilofacial area.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

0052

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.