DIGORA OPTIME (OR DIGORA ONTIME)

K041050 · Soredex Palodex Group OY · MUH · Jun 15, 2004 · Dental

Device Facts

• Record ID: K041050
• Device Name: DIGORA OPTIME (OR DIGORA ONTIME)
• Applicant: Soredex Palodex Group OY
• Product Code: MUH · Dental
• Decision Date: Jun 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Digora Optime imaging system is indicated for capturing, digitization and The Digord Optime Images stored in imaging plate recording media.

Device Story

Digora Optime is a digital radiography system for intra-oral imaging. It uses reusable imaging plates placed in disposable bags to record x-ray energy as a latent image. The device scans the plate pixel-by-pixel using a laser, releasing stored energy as optical emission. An optical system collects this emission, and a photo-electronic system converts it into digital signals. These signals are processed, formatted, and stored by a computer system. The device is used in clinical settings by dental professionals. Auxiliary software (e.g., Digora for Windows) on a PC is required for further image processing, display, and archiving. The system improves diagnostic capability through higher bit-depth (14-bit vs 8-bit) and improved spatial resolution (10 lp/mm) compared to the predicate, aiding clinicians in dental diagnosis.

Clinical Evidence

Bench testing only. Comparison of signal-to-noise ratio and spatial resolution against the predicate Digora system. Results showed equivalent dose requirements for specific pixel values and improved spatial resolution (10 lp/mm for Optime vs 8 lp/mm for Digora).

Technological Characteristics

Digital radiography system; reads imaging plates (sizes 0, 1, 2, 3); 14-bit depth; laser scanning stimulation; photo-electronic signal conversion; PC-based processing; connectivity via auxiliary software.

Indications for Use

Indicated for capturing and digitizing intra-oral radiographic images stored on imaging plate recording media.

Regulatory Classification

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.

Predicate Devices

• Digora (K934949)

Reference Devices

• Digora for Windows (K983267)

Submission Summary (Full Text)

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KOH i 050

Image /page/0/Picture/1 description: The image shows the logo for Soredex. The logo consists of the word "SOREDEX" in a bold, italicized font. Above the word is a black, triangular shape with a curved top edge. A thin, vertical line connects the triangle to the top of the word "SOREDEX".

JUN 1 5 2004

# 510(k) Summary

Date April 19, 2004

# Submitters Information

Soredex Instrumentarium Corporation Elimaenkatu 22 00510 Helsinki Finland Phone: Contact:

Trade Name Digora Optime (or Ontime)

Common Name Imaging plate reader

# Classification

Solid state x-ray imager

Predicate Device Digora

510(k): K934949

# Product Description

A digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.

Further image processing, display and achieving are carried out with an auxiliary software (such as Digora for Windows K983267), a PC.

510(k) Diaora Optime

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#### Intended Use

Intentied USC
The Digora Optime imaging system is indicated for capturing, digitization and The Digord Optime Images stored in imaging plate recording media.

# Technological Characteristics

Technological onaracter.org to spability of reading imaging plates, which in size correspond to the number 0,1,2 and 3 intra oral films.

conespond to the number of , = sheate device is 8 bits and correspondingly in the subject device 14 bits.

#### Performance data

r errormanoc data A companion botwoon bigenalue of a known object and the spatial resolution. The dose required to for a certain pixel-value was equivalent of that required for Digora. Spatial resolution for Digora is 8 lp/mm, and 10 lp/mm for Digora Optime.

#### Conclusion

Digora Optime has found to have substantially equivalent physical performance as the predicate device Digora.

Digora Optime has also be shown to be able to provide images of equivalent or slightly better diagnostic capability to the predicate device Digora.

Digora Optime is as safe and effective as the predicate device.

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Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 5 2004

Mr. Kai Lanér Director Soredex Instrumentarium Corporation Elimaenkatu 22 B Helsinki FINLAND

Re: K041050 Trade/Device Name: Digora Optime (or Digora Ontime) Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 MQB Dated: April 19, 2004

Received: April 22, 2004

Dear Mr. Lanér:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endobard) vo vogany - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 continer & proct to may 20, 1973) in accordance with the provisions of the Federal Food, DNIg, devices that have been resulted to require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mantes of the Act include requirements for annual registration, listing of general controls provisions of tractice, 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 If your device is classinod (600 a0010) ads. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a Pr may be subject to save additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obancements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a device complies with other requirements of the Act that FDA has made a decemination may Juinistered by other Federal agencies. You must comply of ally I edelal statures and regalanced as but not limited to: registration and listing (21 CFR Part with an the Ace 3 requirements, mere and manufacturing practice requirements as set forth in the 807), laboling (21 OF R Far 807), govern 820); and if applicable, the electronic product quality Systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ocgin manieting your device of your device to a legally premarket notification. The I DA micing of basification 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 If you desire specific advice for your device of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the prosses note the regulation entitled, "Misbranding Other of Compinance at (201) 37 . or (21CFR Part 807.97) you may obtain. Other general by relerence to premation (21 the Act may be obtained from the Division of Small mormation on your responsionities and creation at its toll-free number [phone] or Manufacturers, International and Golless http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

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 : K041050

DEVICE NAME :

DIGORA OPTIME (or DIGORA ONTIME)

INDICATIONS FOR USE :

The Digora Optime imaging system is indicated for capturing, digitization The Digora Optime Imaging System is inalities in imaging plate recording media.

Daniel L. Seymour

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041050

*Prescription Use*