OP300

K122018 · Palodex Group OY · OAS · Dec 10, 2012 · Radiology

Device Facts

• Record ID: K122018
• Device Name: OP300
• Applicant: Palodex Group OY
• Product Code: OAS · Radiology
• Decision Date: Dec 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The unit must only be used and operated by dentist and other qualified professionals. The unit must only be used to take panoramic. cephalometric and 3D images of the dento-maxillofacial complex of the human skull. It must not be used to take images of any other part of the human body.

Device Story

OP300 is an extraoral, software-controlled dental X-ray system. It captures 2D panoramic, cephalometric, and TMJ images, and 3D projection images via cone beam rotation around the patient's head. Input data consists of X-ray projections captured by CMOS flat panel detectors. The system reconstructs 3D volumes from these projections using Filtered Back Projection (FBP) or Algebraic Reconstruction Technique (ART). Operated by dentists or qualified professionals in clinical settings, the device produces digital images for viewing on 3D software. Clinicians use these images to visualize the dento-maxillofacial complex, aiding in diagnostic and treatment planning decisions. The device benefits patients by providing high-resolution diagnostic imaging of the skull and jaw structures.

Clinical Evidence

No clinical testing was conducted. Evidence consists of non-clinical bench testing, specifically an image quality preference study comparing the subject device to the predicate. Internal reviewers and external dental professionals evaluated reconstructed images from identical patient data. Software validation was performed to ensure safety and effectiveness.

Technological Characteristics

Extraoral dental X-ray system; CMOS flat panel detectors; 0.5mm focal spot; 3D field of view 61x41mm or 61x78mm; 200-degree viewing angle; 80-350 µm voxel size. Energy source: pulsed X-ray (3D mode). Connectivity: digital output for 3D viewing software. Reconstruction algorithms: FBP and ART. System footprint: H161-241cm x D1390cm x W97-193cm. Weight: 205-250kg.

Indications for Use

Indicated for dental radiographic examination of teeth, jaw, and TMJ areas in patients requiring 2D panoramic, cephalometric, or 3D cone beam computed tomography imaging of the dento-maxillofacial complex. Contraindicated for imaging any body part other than the human skull.

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

• OP300 (K093683)

Submission Summary (Full Text)

{0}------------------------------------------------

K122018

Attachment 7

# 510(k) Summary

DEC 1 0 2012

Date: November 2, 2012

#### Manufacturer:

PaloDEx Group Ov Nahkelantie 160 04300 Tuusula, Finland

Tel: [phone] Fax: [phone]

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

## Trade Name:

OP300

### Common Name:

Dental panoramic, cephalometric and cone beam computed tomography xray device

#### Classification Name:

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

#### Description:

The Orthopantomograph OP300 is an extraoral source, software-controlled dental x-rav device which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software.

#### Intended Use:

The unit must only be used and operated by dentist and other qualified professionals. The unit must only be used to take panoramic. cephalometric and 3D images of the dento-maxillofacial complex of the human skull. It must not be used to take images of any other part of the human body.

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

# Summary of Technological Characteristics:

.

OP300 is substantially equivalent in design, composition and function to the current OP300 unit.

:

··

.

.
1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 1992 – 199

.

. .

i

... ...

. ·

. .

י

. •

,

| Concept | | OP300 (Modified) | OP300 [K093683] |
|---------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Indications for Use | The OP300 dental panoramic,<br>cephalometric and cone beam computed<br>tomography x-ray device is intended for<br>dental radiographic examination of teeth,<br>jaw and TMJ areas by producing<br>conventional 2D x-ray images as well as x-<br>ray projection images of an examined<br>volume for the reconstruction of a 3D<br>view. | Same |
| 2. | Imaging modes | Panoramic, Cephalometric, TMJ, 3D | Same |
| 3. | X-ray source | 3D mode: 90Kv<br>Pan mode: 57-90 kV<br>Ceph mode: 60-90 kV<br>kV accuracy: +/-5kV<br>mA range: 3.2-16 mA<br>3D power mode: pulsed | 3D mode: 90kV<br>Pan mode: 57-90 kV<br>Ceph mode: 60-90 kV<br>kV accuracy: +/-5kV<br>mA range: 2-16 mA<br>3D power mode:<br>pulsed/continuous · |
| 4. | Focal spot | 0.5mm | Same |
| 5. | Image detector(s) | CMOS Flat Panel<br>+ CMOS for pan/ceph imaging | Same |
| 6. | 3D imaging technique | Reconstruction from 2D images | Same |
| 7. | 3D's Field Of View | 61 x 41 mm<br>61 x 78 mm | Same |
| 8. | 3D's total viewing angle | 200 degrees | Same |
| 9. | Pixel size | CMOS flat panel for 3D: 200 um<br>CMOS for panoramic imaging: 100 um | Same |
| 10. | Voxel size | 80-350 µm | Same |
| 11. | Reconstruction Software | Filtered Back Projection (FBP) or<br>Algebraic Reconstruction Technique (ART) | Algebraic Reconstruction<br>Technique (ART) |
| 12. | 3D's effective exposure time | 2.3 - 12.5 sec | 2 - 20 sec |
| 13. | 3D Reconstruction Time | 1-3 min | Same |
| 14. | Patient's Position | Standing and wheelchair | Same |
| 15. | System footprint | H161-241cm x D1390cm x W97-193 cm | Same |
| 16. | Weight | Pan/3D 205 kg<br>Ceph 250 kg | Same |

{2}------------------------------------------------

#### Non-clinical Test Data:

Preference study as an image quality comparison between OP300 and the predicate device was performed. Same patient data was used for the reconstructions and the images were evaluated by internal reviewers and external dental professionals. Validations have been performed successfully to ensure the safety and effectiveness of the OP300 system.

#### Clinical Test Data:

Clinical testing has not been conducted on OP300 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 [OP300, K093683] and the successful validation of the OP300 software, the clinical performance of the OP300 is deemed to be substantially equivalent to the predicate devices.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is smaller than the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 10, 2012

PaloDEx Group OY C/O Mr. Matti Tulikoura Regulatory Manager Nahkelantie 160 TUUSULA 04300 FINLAND

Re: K122018

Trade/Device Name: OP300 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: November 5, 2012 Received: November 7, 2012

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 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.

{4}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Janine M. Morris -S

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

Enclosure

{5}------------------------------------------------

# Indications for Use

#### 510(k) Number (if known): . K122018

Device Name: OP300

Indications for Use:

The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals. Prescription ·

Prescription Use - X (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 (OIR) Janine M. Morris -S 2012.12.10 12:34:35 -05'00'

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

K122018 __ 510(k)________________________________________________________________________________________________________________________________________________________________________

Page 1 of