PANOURA 18S

K111231 · The Yoshida Dental Mfg. Co., Ltd. · MUH · Jul 13, 2011 · Dental

Device Facts

• Record ID: K111231
• Device Name: PANOURA 18S
• Applicant: The Yoshida Dental Mfg. Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Jul 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.

Device Story

Panoura 18S is a digital extraoral X-ray system for dental imaging. Device consists of X-ray generator, sensor unit, arm, column, and sliding body. During operation, arm rotates around patient's head; X-ray source irradiates teeth/jaw; sensor captures multiple X-ray absorption data points. Data transferred to image processing unit; system superimposes data using shift values synchronized with arm rotation speed to reconstruct 2D panoramic or cephalometric images. Used in dental clinics by dentists or qualified professionals. Output provides diagnostic images for clinical decision-making regarding dental, jaw, and TMJ health. Benefits include non-invasive visualization of oral structures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included software verification/validation and risk analysis to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Digital panoramic/cephalometric X-ray system. Oil-cooled X-ray tube (0.5mm x 0.5mm focal spot). Tube voltage 58-82kV; tube current 2.0-10mA. Single-phase power. Total filtration >= 2.5mm Al. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60825-1, 61223-3-4, IEC 62304, ISO 14971.

Indications for Use

Indicated for dental radiographic examinations of teeth, jaw, and TMJ areas in patients requiring 2D X-ray or projection imaging. For use by dentists and qualified professionals only.

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

• ORTHOPANTOMOGRAPH OP300 (K093683)

Submission Summary (Full Text)

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K111231

PANOURA 18S PREMARKET NOTIFICATION 510(k)

# Section 6- 510(k) Summary

JUL 1 3 2011

a. Owner/Company name, address THE YOSHIDA DENTAL MFG. CO., LTD. 1-3-6, Kotobashi, Sumida-ku Tokyo 130-8516, Japan

Michizo Yamanaka President

" Contact person Hidenori Watanabe International Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail] Email:

# b. Contact/Application Correspondent

Fumiaki Kanai, Ph.D. President and CEO MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

Phone: [phone] Fax: [phone] Email. [e-mail]

# c. Date prepared

April 29, 2011

# d. Name of device

Trade Name: Panoura 18S Common Name: Extraoral source x-ray system Classification Name: System, x-ray, extraoral source, digital Classification Regulation: 21 CFR 872.1800

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### PANOURA 18S PREMARKET NOTIFICATION 510(k)

# e. Predicate devices

The PANOURA 18S is substantially equivalent to the following legally marketed device:

| 510(k): | K093683 |
|---------------|--------------------------|
| Trade name: | ORTHOPANTOMOGRAPH OP300- |
| Product code: | MUH |

The predicate device is hereinafter called "the ORTHOPANTOMOGRAPH (k093683)" in this application.

# f. Description of the device

The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The PANOURA 18S is equipped with an X-ray generator and a Sensor unit at Arm unit supported by Column unit and Sliding body unit. While rotating around the patient's teeth and jaw, the PANOURA 18S irradiates X-ray and detects X-ray absorbed data at the Sensor unit multiple times. Detected multiple data are transferred to an image processing unit and the data are superimposed with appropriate shift value according to the X-ray moving speed from the arm rotation to acquire image.

# g. Indications for Use

The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.

# h. Statement of substantial equivalence

The characteristics of the PANOURA 18S are similar to those of the ORTHOPANTOMOGRAPH (k093683) listed in part e. The similarities are:

- Intended use .
- . Operational characteristics
- . Ionizing radiation
- . Cephalometric radiogram
- Panoramic images by producing conventional 2D X-ray images as well as X-ray . projection images

Difference regarding intended use between the Panoura 182 and the ORTHOPANTOMOGRAPH (k093683) is that the ORTHOPANTOMOGRAPH (k093683) has following additional intended use compared to the PANOURA 18S:

- 1. Cone Beam Computerized Tomography
- 2. Producing X-ray projection of 3-D

In order to evaluate safety and effectiveness of the PANOURA 18S, software verification/validation, performance testing, and risk analysis were performed. In conclusion,

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## PANOURA 18S PREMARKET NOTIFICATION 510(k)

those testing and analysis demonstrated that the PANOURA 18S did not raise any new safety or effectiveness concerns compared to the ORTHOPANTOMOGRAPH (k093683)

#### Comparison table i.

Table 6-1 compares the characteristics between the PANOURA 18S and the ORTHOPANTOMOGRAPH (k093683).

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| PANOURA 18S |
|-------------------------------|
| PREMARKET NOTIFICATION 510(k) |

# son Tahl Tahle

| | Device Characteristics | PANOURAIS | ORTHOPANTOMOGRAPH (k093683) | |
|--|-------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------------|---------------------------|
| | Equipment type | Digital panoramic x-ray equipment | Digital panoramic x-ray equipment | |
| | Mode of operation | Continuous operation with intermittent load | Continuous operation with intermittent load | |
| | X-ray tube focal point | 0.5 mm×0.5 mm | 0.5 mm×0.5 mm | |
| | X-ray tube cooling method | Oil cooling | Oil cooling | |
| | Nominal maximum electric power<br>(combination of X-ray tube voltage<br>and tube current at maximum output) | 0.82kW (82kV, 10mA) | 1.44kW (90kV, 16mA) | |
| | Tube voltage | 58 - 82kV | 57 - 90kV | |
| | Tube current | 2.0 - 10mA | 4 - 16mA | |
| | Radiation time | Adult | 16.4s | |
| | | Panoramic | 8, 14, 16s | |
| | | Child | 6.4, 11.2, 12.8s | 14.4s |
| | TMJ | 8s | 10.6s | |
| | Cephalo / Carpus image acquisition | 8 - 10 s | 10-20s | |
| | Electric power supply resistance | Maximum 0.2 Ω | Maximum 0.2 Ω | |
| | Total filtration | 2.5mmAl equivalent or over | 3.2mm Al equivalent or over | |
| | Leakage dose | 1.0 mGy/h or less | 1.0 mGy/h or less | |
| | Leakage dose calculation standards | Tube voltage 82kV, tube current 10mA | Tube voltage 90kV, tube current 4mA | |
| | Number of phases | Single phase | Single phase | |
| | Frequency | 50 / 60 Hz | 50 / 60Hz | |
| | Rated power | Voltage | AC100V - 120V / AC220V | AC100 - 240V (Selectable) |
| | | Input | 110VAC<br>230VAC | 2.0kVA<br>2.0kVA |
| | Classification | Class I, Type B | Class I, Type B | |

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PANOURA 18S
PREMARKET NOTIFICATION 510(

| Device Characteristics | PANOURA 18S | ORTHOPANTOMOGRAPH (K093683) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Weight | 125kg Standing position wall mount<br>120kg Standing position wall mount (short type)<br>150 kg (with an optional base)<br>145kg Standing position base mount short type with an<br>optional base/ 150kg with wide base<br>190kg Standing position wall mount (with Cephalo)<br>185kg Standing position wall mount short type (with<br>Cephalo)<br>215kg Standing position base mount with Cephalo and<br>optional base<br>210kg Standing position base mount short type with<br>Cephalo and optional base/ 215kg with wide base | 200kg (Panoramic)<br><br>240kg (Cephalo) |
| Size | 2209 x 849 x 1192mm(Standing position wall mount)<br>2209 x 1759 x 1192mm(Standing position wall-mount<br>with Cephalo) | 2410 x 830 x 1126mm (standard column)<br>2410 x 1931 x 1193 mm (with Cephalo*) |
| EMC Classification | ClassA | Class B |
| Target angle | 15 degrees | 5 degrees |
| Cephalometric<br>radiogram | Scanning method<br>Horizontal scan, synchronized<br>sensor and secondary slot motion | Scanning method<br>Horizontal scan, synchronized<br>sensor and secondary slot motion |
| | Scanning time<br>8 - 10s | Scanning time<br>10 - 20s |

THE YOSHIDA DENTAL MFG. CO., LTD.
APRIL 29, 2011

# SECTION 6
6- 6 OF 6-7

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#### Compliance with recognized consensus or voluntary standards j.

The following recognized consensus or voluntary standards were used (as applicable) for the Extraoral source x-ray system classified in 21 CFR 872.1800. The PANOURA 18S meets the requirements of the recognized consensus or voluntary standard.

| Standards<br>No. | Standards<br>Organization | Standards Title | Date |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 60601-1 | UL | Medical Electrical Equipment, Part 1: General Requirements for<br>Safety, A1:1991/A2:1995 | 2003 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests. A1:2004 | 2004 |
| 60601-1-3 | IEC | Medical electrical equipment - Part 1-3: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Radiation protection in diagnostic X-ray equipment | 1994 |
| 60601-2-7 | IEC | Medical electrical equipment - Part 2-7: Particular requirements for<br>the safety of high-voltage generators of diagnostic X-ray generators | 1998 |
| 60601-2-28 | IEC | Medical electrical equipment - Part 2-28: Particular requirements<br>for the basic safety and essential performance of X-ray tube<br>assemblies for medical diagnosis | 1993 |
| 60601-2-32 | IEC | Medical electrical equipment - Part 2: Particular requirements for<br>the safety of associated equipment of X-ray equipment | 1994 |
| 60825-1 | IEC | Safety of laser products - Part 1: Equipment classification and<br>requirements | 2007 |
| 61223-3-4 | IEC | Evaluation and routine testing in medical imaging departments -<br>Part 3-4: Acceptance tests - Imaging performance of dental X-ray<br>equipment | 2000 |
| 62304 | IEC | Medical device software - Software life cycle processes | 2006 |
| 14971 | ISO | Medical devices - Application of risk management to medical<br>devices | 2007 |

# k. Conclusion

The PANOURA 18S has the same intended use except regarding computerized tomography and reconstructed 3-D image and similar operational and technological characteristics as the ORTHOPANTOMOGRAPH (k093683). The performance test results indicate that the PANOURA 18S meets the requirements of recognized consensus or voluntary standard. Based on the information presented above above regarding substantial equivalence to the ORTHOPANTOMOGRAPH (k093683), THE YOSHIDA DENTAL MFG. CO., LTD. concludes that the PANOURA 18S is substantially equivalent to the ORTHOPANTOMOGRAPH (k093683) and does not raise any new questions regarding safety or effectiveness.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

The Yoshida Dental MFG Co., Ltd. % Fumiaki Kanai, Ph.D. President and CEO MIC International 4.1.17 Hongo, Bunkyo-ku Tokyo, 113-0033 JAPAN

Re: K111231

JUL 1 3 2011

Trade/Device Name: Panoura 18S Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 29, 2011 Received: May 2, 2011

# Dear Dr. Kanai:

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 (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 (QS) 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/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/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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# Indications for Use

510(k) Number (If known):

Device Name: Panoura 18S

# Indication for Use

The PANOURA 18S dental panoramic and cephalometric device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D X-ray images as well as X-ray projection images. The device must only be operated and used by dentists and other legally qualified professionals.

Image /page/8/Picture/5 description: The image shows the words "Prescription Use" in bold font. Below that, the text "(Per 21 CFR 801 Subpart D)" is shown. To the right of the words "Prescription Use" is a large X.

AND/OR

Over-the Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Postel
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K111231