SCANORA 3D

K110839 · Soredex Palodex Group OY · OAS · Jun 30, 2011 · Radiology

Device Facts

• Record ID: K110839
• Device Name: SCANORA 3D
• Applicant: Soredex Palodex Group OY
• Product Code: OAS · Radiology
• Decision Date: Jun 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The unit must only be used and operated by qualified healthcare professionals. The unit must only be used to take 3D and (OPTIONAL) panoramic images of the dentomaxillofacial complex and the head and neck areas, including the ear, nose and throat (ENT) areas of the human skull. It must not be used to take images of any other part of the human body.

Device Story

Scanora 3D is a cone beam computed tomography (CBCT) system for dentomaxillofacial and head/neck imaging. Device rotates around patient head, emitting conical X-ray beam; captures 2D projection images via flat panel detector. System reconstructs 3D images from 2D projections; optional CCD detector enables classical panoramic and TMJ imaging. Operated by qualified healthcare professionals in clinical settings. Output viewed via 3rd party software to support diagnostic decision-making. Benefits include high-resolution 3D visualization of complex anatomical structures for improved diagnostic accuracy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and image quality comparisons against predicate devices.

Technological Characteristics

X-ray source: 90 kV, 4-12.5 mA (3D mode); 60-81 kV, 4-8 mA (Pan mode). Detectors: CMOS flat panel (3D), CCD (Pan). 3D imaging via 2D projection reconstruction. Voxel sizes: 133-350 µm. Connectivity: 3rd party software for viewing. System footprint: 197cm x 140cm x 160cm. Weight: 310 kg.

Indications for Use

Indicated for diagnostic support imaging of the head and neck, including ENT and dentomaxillofacial areas in humans. Optional dedicated panoramic imaging. Operated by qualified healthcare professionals.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Scanora 3D (K073350)
• Morita 3D Accu-I-tomo 170 XYZ Slice view Tomograph (K073695)

Submission Summary (Full Text)

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ARRETTING OUR BELLERS FOR

## 510(k) Summary

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Date:

MARES 2017

22 March 2011

Recomment

JUN 3 0 2011

110839

### Manufacturer:

SOREDEX, PaloDEx Group Oy P.O.Box 148 (Street address: Nahkelantie 160) FIN-04301 Tuusula, Finland

Tel: [phone] Fax: [phone]

Contact person: Mr. Matti Tulikoura, Tel [phone]

United States Sales Representative (U.S. Designated agent):

1245 W. Canal St. Milwaukee, WI 53233 U.S.A. Tel. [phone] Fax [phone]

Contact Person: Mr. Frank Kashinski, Tel [phone]

Trade Name: Scanora 3D

## Common Name:

Cone beam 3D X-ray system

## Classification Name:

Extraoral source X-ray system (21 CFR 872.1800, product code MUH) Computed tomography x-ray system (21 CFR 892.1750, product code JAK)

#### Description:

Scanora 3D is a Cone beam 3D x-ray system for Dentomaxillofacial and Head & Neck (ENT) imaging. Dedicated panoramic imaging is an option. In CT mode it generates a conical x-ray beam during rotation around a patient's head and produces two dimensional projection images on a flat panel detector. Three dimensional images are then reconstructed and viewed with 3rd party software. In panoramic mode panoramic and TMJ images can be taken in the classical way on a separate CCD detector.

SOREDEX PaloDEx Group Oy Nahkelantie 160 P.O.Box 148 -04301 Tuusula. Finland 1 [phone] Fax + 358 9 701 5261 [e-mail] www.soredex.com VAT FI 198 10468

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## Intended Use:

The unit must only be used and operated by qualified healthcare professionals.

The unit must only be used to take 3D and (OPTIONAL) panoramic images of the dentomaxillofacial complex and the head and neck areas, including the ear, nose and throat (ENT) areas of the human skull. It must not be used to take images of any other part of the human body.

## Summary of Technological Characteristics:

Scanora 3D is substantially equivalent in design, composition and function to the current Scanora 3D unit as well as to another unit currently marketed by J. Morita USA, Inc.

| | Concept | SCANORA 3D | SCANORA 3D<br>(K073350, MUH/JAK) | Morita 3D Accu-I-tomo 170 XYZ Slice view Tomograph (K073695, JAK) |
|-----|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 1. | x-ray source | 3D mode: 90 kV, 4-12.5 mA, pulsed.<br>Pan mode: 60-81 kV, 4-8 mA continuous.<br>kV accuracy +/5kV,<br>Same x-ray source for 3D and Pan modes. | 3D mode: 85 kV, 8-15 mA, pulsed.<br>Pan mode: 60-81 kV, 4-8 mA continuous.<br>kV accuracy +/5kV,<br>Same x-ray source for 3D and Pan modes. | 60-90 kV, 1-10 mA continuous |
| 2. | Focal spot | 0.5 mm | 0.5 mm | 0.5 mm |
| 3. | Image detector(s) | CMOS Flat Panel + CCD for panoramic imaging | CMOS Flat Panel + CCD for panoramic imaging | Amorphous Silicon Flat Panel |
| 4. | 3D imaging technique | Reconstruction from 2D images | Reconstruction from 2D images | Reconstruction from 2D images |
| 5. | 3D's Field Of View | H60 x Ø60 mm<br>H75 x Ø100 mm<br>H75 x Ø145 mm<br>H130xØ145 mm – stitched | H60 x Ø60 mm<br>H75 x Ø100 mm<br>H75 x Ø145 mm | H40 x Ø40 mm<br>H60 x Ø60 mm<br>H80 x Ø80 mm<br>H100 x Ø100 mm<br>H120 x Ø170 mm |
| 6. | 3D's total viewing angle | 360 degrees | 360 degrees | 180/360 degrees |
| 7. | Pixel size | CMOS Flat panel: 200 µm<br>CCD for panoramic imaging: 48 µm | CMOS Flat panel: 200 µm<br>CCD for panoramic imaging: 48 µm | 127 µm |
| 8. | Voxel size | 133/200/250/<br>300/350 µm | 133/200/250/<br>300/350 µm | 80/125/160/250 µm |
| 9. | 3D scan time | 10 - 26 sec | 10 - 20 sec | 5.4 - 30.8 sec |
| 10. | 3D's effective exposure time | 2.25 - 6 sec | 2.25 - 4.5 sec | 5.4 - 30.8 sec |

SOREDEX

PaloDEx Group Oy Nahkelantie 160 P.O.Box 148 "-04301 Tuusula, Finland 1 [phone] "Fax + 358 9 701 5261 [e-mail] www.soredex.com VAT FI 198 10468

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Image /page/2/Picture/1 description: The image shows the word "SOREDEX" in bold, black letters. The first letter, "S", is stylized with a sharp, angular design on its left side. The remaining letters are in a standard, sans-serif font, creating a strong visual impact. The word appears to be a logo or brand name, presented in a clear and legible manner.

| 11. | Indications for use | Scanora 3D is a Cone Beam<br>3D x-ray system for imaging<br>the head and neck areas,<br>including the ENT and<br>dentomaxillofacial areas, for<br>use in diagnostic support.<br>Dedicated panoramic<br>imaging is an option. A flat<br>panel detector is used to<br>acquire 3D images and an<br>optional CCD sensor to<br>acquire panoramic images.<br>The device is operated and<br>used by qualified healthcare<br>professionals. | Scanora 3D is a dental<br>cone beam computed<br>tomography x-ray<br>system intended to<br>image teeth, jaw and<br>TMJ areas of the skull.<br>A flat panel detector is<br>used to acquire 3D<br>images and an optional<br>CCD sensor to acquire<br>panoramic images. The<br>device is operated and<br>used by dentists and<br>other qualified<br>professionals. | The Model MCT-1EX-<br>1F8/F17 is an x-ray<br>imaging device that<br>acquires a 360 degree<br>rotational sequence of<br>the head and neck areas,<br>including the ENT and<br>dentomaxillofacial areas,<br>for use in diagnostic<br>support. The device<br>accomplishes this task by<br>reconstructing a three<br>dimensional matrix of<br>the examined volume<br>and producing two<br>dimensional views of this<br>volume, displaying both<br>two and three<br>dimensional images.<br>The device is operated<br>and used by physicians,<br>dentists and x-ray<br>technologists. |
|-----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 12. | System footprint | H197cm x<br>D140cm x<br>W160cm | H197cm x<br>D140cm x<br>W160cm | H208cm x D120cm x<br>W162cm |
| 13. | Weight | 310 kg | 310 kg | Approx. 400 kg |

#### Non-clinical Test Data:

Bench test image quality comparison between the Scanora 3D and the predicate devices was performed.

The Scanora 3D software has been successfully validated to confirm the performance of this device.

#### Clinical Test Data:

Clinical testing has not been conducted on this device.

#### Conclusion:

Based upon the similar technological/performance characteristics and image comparison as compared to the predicate devices and successful validation of the Scanora 3D software, the clinical performance of the Scanora 3D is deemed to be substantially equivalent to the predicate devices.

SOREDEX PaloDEx Group Oy Nahkelantie 160 P.O.Box 148 "-04301 Tuusula, Finland 1 [phone] ˜ѓах + 358 9 701 5261 [e-mail] www.soredex.com VAT FI 198 10468

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Public Health Service

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

JUN 3 0 2011

Mr. Matti Tulikoura Regulatory Manager SOREDEX. PaloDEx Group Oy P.O. Box 148 (Street address: Nahkelantie 160) FIN-04301 Tuusula FINLAND

Re: K110839

Trade/Device Name: Scannora 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: June 23, 2011 Received: June 27, 2011

Dear Mr. Tulikoura:

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 of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone]. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. 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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SOREDEX

# Indications for Use

510(k) Number (if known):

Device Name: _Scanora 3D

Indications for Use:

Scanora 3D is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option. A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images. The device is operated and used by qualified healthcare professionals.

× Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Spastel
Division Sign Off

Division Sian-6 Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110839

SOREDEX PaloDEx G Nahkelantie Tuc P.O.Box 148 04301 Tuusula, Finland 2000 07 00 858 ﺍﻟﺘ Fax + 358 9 701 5261 [e-mail] www.soredex.com VAT FI 198 10468

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