SCANORA 3DX

K130297 · Palodex Group OY · OAS · May 29, 2013 · Radiology

Device Facts

• Record ID: K130297
• Device Name: SCANORA 3DX
• Applicant: Palodex Group OY
• Product Code: OAS · Radiology
• Decision Date: May 29, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The unit must only be used to take 3D and (optional) panoramic images of the dento-maxillo-facial complex and the head and neck areas, including the ear, nose and throat (ENT) areas of the human skull. The unit must not be used to take images of any other part of the human body. Note that panoramic and 3D exposures should not be used if conventional intraoral radiographic images (bitewing exposures) would suffice. Note that cone beam computerized tomography images are not adequate for the analysis of soft tissue. Always use the lowest possible exposure values that will allow you to take an image of sufficient quality for you to perform the required diagnostic examination.

Device Story

SCANORA 3Dx is a cone beam computed tomography (CBCT) system for dentomaxillofacial and head/neck imaging. Device rotates around patient head, generating conical x-ray beam; captures 2D projections via amorphous silicon flat panel detector (3D mode) or optional CCD sensor (panoramic mode). System reconstructs 3D images from 2D projections; viewed via 3rd party software. Operated by qualified healthcare professionals in clinical settings. Output provides diagnostic support for bone structures; assists clinicians in treatment planning. Benefits include high-resolution 3D visualization of hard tissues in head/neck region.

Clinical Evidence

No clinical data conducted. Evidence consists of bench testing and a preference study comparing image quality between SCANORA 3Dx and the predicate SCANORA 3D using a phantom. Results evaluated by internal reviewers to confirm safety and effectiveness.

Technological Characteristics

CBCT system; 90 kV, 4-10 mA pulsed x-ray source (3D mode); 0.5 mm focal spot. Detectors: Amorphous Silicon Flat Panel (3D) and CCD (panoramic). Voxel sizes: 100-500 µm. Field of View: up to 240x165 mm (stitched). Connectivity: 3rd party software for viewing. Software: FBP (Filtered Back Projection) reconstruction algorithm.

Indications for Use

Indicated for diagnostic support imaging of the head and neck, including ENT and dentomaxillofacial areas, in patients requiring 3D or panoramic radiographic assessment. Operated by qualified healthcare professionals. Contraindicated for soft tissue analysis and when conventional intraoral bitewing radiographs suffice.

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 (K110839)

Submission Summary (Full Text)

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K130297
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# PALODEX GROUP

### MAY 2 9 2013

### 510(k) Summary

Date: February 4th, 2013

PalaDEx Group Ox

. palodex group. com

Street addre Nahkelantie 160 04300 Tuusuta Finland

Postal address P.O. Box 64 FI-0430 | Tuusula Finland

[phone]

Fas [phone]

VAT F119774137

BI code 1977413-7

Bank Nordea Bank SWIFT NDEAFIHH Account F19015963000046864

### Manufacturer:

PaloDEx Group Oy Nahkelantie 160 Tuusula, Finland 04300

Tel: [phone] Fax: [phone]

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

Trade Name: SCANORA 3Dx

Common Name: Cone beam 3D X-ray system

### Classification Name:

Computed tomography x-ray system (21 CFR § 892.1750, product code OAS)

### Description:

Scanora 3Dx is a Cone Beam Computerized Tomography 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.

### Intended Use:

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

Note that panoramic and 3D exposures should not be used if conventional intraoral radiographic images (bitewing exposures) would suffice. Note that cone beam computerized tomography images are not adequate for the analysis of soft tissue.

Always use the lowest possible exposure values that will allow you to take an image of sufficient quality for you to perform the required diagnostic examination.

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## PaloDEx Group

### Indication For Use

SCANORA 3Dx 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.

PaloDEx Group Oy

www.pzlodexgroup.com

Street address Nahkelantic 160 04300 Tuusula Finland

Postal address P.O. Box 64 Fi-04301 Tuusula Finland

Phone [phone]

Fax 4.350 9 B51 4048

.

VAT F119774137

Bi code 1977413-7

Bank Nordea Bank SWIFT NDEAFIHH Account F19015963000046864

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# PALODEX GROUP

### Summary of Technological Characteristics:

SCANORA 3Dx is substantially equivalent in design, composition and function to the current SCANORA 3D unit [K110839].

PatoDEx Group Oy

www.patodexgroup.com

- Street address Nahkelantie | 60 04300 Tuusula Finland
Postal address P.O. Box 64 FI-04301 Tuusula Finland

Phone [phone]

Fax [phone]

VAT FI19774137

BI code
1977413-7

Bank Nordea Bank swift NDEAFIHH Account F190 | 5963000046864

.

| Concept | | SCANORA 3Dx | SCANORA 3D [K110839] |
|---------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | X-ray source | 3D mode: 90 kV, 4-10 mA, pulsed. | 3D mode: 90 kV, 4-12.5 mA, pulsed. |
| | | Pan mode: 60-81 kV, 4-8 mA continuous. | Pan mode: 60-81 kV, 4-8 mA<br>continuous. |
| | | kV accuracy +/5kV, | kV accuracy +/5kV, |
| | | Same x-ray source for 3D and Pan<br>modes. | Same x-ray source for 3D and Pan<br>modes. |
| 2. | Focal spot | 0.5 mm | 0.5 mm |
| 3. | Image<br>detector(s) | Amorphous Silicon Flat Panel | CMOS Flat Panel |
| | | + CCD for panoramic imaging | + CCD for panoramic imaging |
| 4. | 3D imaging<br>technique | Reconstruction from 2D images | Reconstruction from 2D images |
| 5. | 3D's Field Of<br>View | H50 x Ø50 mm<br>H50 x Ø100 mm<br>H80 x Ø100 mm<br>H140 x Ø100 mm<br>H80 x Ø165 mm<br>H140 x Ø165 mm<br>H180x Ø165 mm - Stitched<br>H240x Ø165 mm - Stitched | H60 x Ø60 mm<br>H75 x Ø100 mm<br>H75 x Ø145 mm<br>H130xØ145 mm - stitched |
| 6. | 3D's total<br>viewing angle | 360 degrees | 360 degrees |
| 7. | Pixel size | Amorphous Silicon flat panel: 120 / 240<br>µm<br>CCD for panoramic imaging: 48 µm | CMOS flat panel: 200 µm<br>CCD for panoramic imaging: 48 µm |
| 8. | Voxel size | 100/150/200/250/300/350/400/500 µm | 133/200/250/300/350 µm |
| 9. | 3D scan time | 18 - 34 sec | 10 - 26 sec |
| 10. | 3D's effective<br>exposure time | 2.4 - 6 sec | 2.25 - 6 sec |
| 11. | Indications for<br>use | Scanora 3D is a Cone Beam 3D x-ray<br>system for imaging the head and neck<br>areas, including the ENT and<br>dentomaxillofacial areas, for use in<br>diagnostic support. Dedicated panoramic<br>imaging is an option. A flat panel detector<br>is used to acquire 3D images and an<br>optional CCD sensor to acquire<br>panoramic images. The device is<br>operated and used by qualified healthcare<br>professionals. | Scanora 3D is a Cone Beam 3D x-ray<br>system for imaging the head and neck<br>areas, including the ENT and<br>dentomaxillofacial areas, for use in<br>diagnostic support. Dedicated<br>panoramic imaging is an option. A flat<br>panel detector is used to acquire 3D<br>images and an optional CCD sensor to<br>acquire panoramic images. The device<br>is operated and used by qualified<br>healthcare professionals. |
| 12. | System<br>footprint | H197cm x D140cm x W160cm | H197cm x D140cm x W160cm |
| 13. | Weight | 310 kg | 310 kg |

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# PALODEX GROUP

### Non-clinical Test Data:

Preference study as an image quality comparison between Scanora 3Dx and the predicate device was performed. Same phantom was imaged with Scanora 3Dx and the predicate Scanora 3D. The results were evaluated by internal reviewers. Validations have been performed successfully to ensure the safety and effectiveness of the Scanora 3Dx system.

### Clinical Test Data:

Clinical testing has not been conducted on Scanora 3Dx device because CBCT imaging technique and FBP algorithm are widely used. Only a preference study was conducted.

#### Conclusion:

Based upon the similar technological/performance characteristics to the predicate device and the successful validation of the SCANORA 3D software, the clinical performance of the SCANORA 3Dx is deemed to be substantially equivalent to the predicate devices.

PaloDEx Graup Oy www.palodexgroup.com

Screet address Nahkelande 160 04300 Tuusula Finland

Postal address P.O. Box 64 FI-0430! Tuusula Finland

Phone [phone]

Fax [phone]

VAT F119774137

ફા દર્ભવ 1977413-7

Bank Nordea Bank swift NDEAFIHH Account £19015963000046864

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

#### Public Health Service

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

May 29, 2013

PaloDEx Group Ov % Mr. Matti Tulikoura Regulatory Manager Nahkelantie 160 Tuusula 04300 FINLAND

Re: 510(k) Number: K130297 Trade/Device Name: SCANORA 3Dx Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: April 21, 2013 Received: April 29, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 – Mr. Tulikoura

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Sm.h.f.)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K130297

Device Name: SCANORA 3Dx

Indications for Use:

Scanora 3Dx 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 × (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 In Vitro Diagnostics and Radiological Health (OlR)

: Smh7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130297 510(k)________________________________________________________________________________________________________________________________________________________________________

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