The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.

Device Description

Cranex Basex D and Cranex Excel D are panoramic extraoral source dental x-ray systems, which produce digital images of dentition. They are modified from the existing Soredex dental panoramic x-ray systems (K880982) by substantially replacing the film image receptor with a digital receptor(CCD). The technique factor settings are constant for the x-ray tube anode voltage (65kV) and current (6 mA DC),

AI/ML Overview

The provided text is a 510(k) summary for the Cranex Basex D and Cranex Excel D dental panoramic x-ray equipment. It states that "Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use." However, it does not contain specific details on acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not specified in the document beyond a general statement that "Verification and validation testing was successfully performed."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the document.
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 in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the document.
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
- The document describes a standalone device (dental panoramic x-ray equipment) that produces digital images; it does not mention any AI component or MRMC comparative effectiveness study involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a standalone medical device (x-ray equipment). Its performance is inherently "standalone" in the sense that it acquires images. The document does not describe an algorithm with standalone performance; it describes the performance of the imaging system itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified in the document.
The sample size for the training set
- Not specified in the document. (This device is not an AI algorithm that would typically have a "training set" in the machine learning sense).
How the ground truth for the training set was established
- Not applicable/Not specified in the document. (As above, this is an imaging device, not an AI algorithm requiring a training set with ground truth in the usual sense).

Summary of available information:

The 510(k) summary for the Cranex Basex D and Cranex Excel D dental panoramic x-ray equipment states that "Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use." However, it does not provide any specific details regarding acceptance criteria, performance metrics, study design, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Soredex. The logo consists of the word "SOREDEX" in a stylized font, with a black, curved shape above it. The curved shape resembles a sail or a stylized wave.

JUL 1 3 2004

510(k) Summary

Kouo382

Date February 10, 2004

Submitters Information

Soredex Instrumentarium Corporation Elimaenkatu 22 B 00510 Helsinki Finland Phone: +358 10 394820 Fax .: +358 9 7015261 Contact: Kai Lanér

Trade Name

Cranex Basex D or Cranex Excel D

Common Name

Dental panoramic x-ray equipment, digital

Classification

System, X-Ray, Extraoral Source, Digital / MUH

Predicate Device

We consider that Cranex Basex D and Cranex Excel D are substantially equivalent in design, composition and function with Orthophos DS (K983057 & K972312).

Product Description

Intended Use

Performance data

Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kai Lanér Soredex Instrumentarium Corporation Ekimaenkatu 22B FIN 00510 Heksinki FINLAND

Re: K040382

Trade/Device Name: Cranex Basex D or Cranex Excel D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: 90 EHD Dated: June 11, 2004 Received: June 14, 2004

Dear Ms. Lanér:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

JUL 1 3 2004

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Broughton

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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Page 1 of 1

510 (k) NUMBER : KOY 0 382

Cranex Basex D and Cranex Excel D DEVICE NAME :

INDICATIONS FOR USE :

Prescription Use

Nancy C. Bragdon

(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
K040382
UK Number

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.