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.

AI/ML Overview

The Panoura 18S is an extraoral x-ray system, which is a medical device and not an AI/ML algorithm. The provided documentation does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ORTHOPANTOMOGRAPH K093683) by comparing technical, operational, and intended use characteristics, and compliance with recognized consensus or voluntary standards for medical electrical equipment and radiation protection.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and performance studies. The provided text describes a traditional medical device submission, not an AI/ML-driven one.

Summary

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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: 011-81-3-3631-2165 Fax: 011-81- 3-3633-9420 hi-watanabe@yoshida-net.co.jp 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: 011-81-3-3818-8577 Fax: 011-81-3-3818-8573 Email. kanaif@mici.co.jp

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

g. Indications for Use

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
1. 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(combination of X-ray tube voltageand 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	110VAC230VAC	2.0kVA2.0kVA
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 mount120kg Standing position wall mount (short type)150 kg (with an optional base)145kg Standing position base mount short type with anoptional base/ 150kg with wide base190kg Standing position wall mount (with Cephalo)185kg Standing position wall mount short type (withCephalo)215kg Standing position base mount with Cephalo andoptional base210kg Standing position base mount short type withCephalo and optional base/ 215kg with wide base	200kg (Panoramic)240kg (Cephalo)
Size	2209 x 849 x 1192mm(Standing position wall mount)2209 x 1759 x 1192mm(Standing position wall-mountwith Cephalo)	2410 x 830 x 1126mm (standard column)2410 x 1931 x 1193 mm (with Cephalo*)
EMC Classification	ClassA	Class B
Target angle	15 degrees	5 degrees
Cephalometricradiogram	Scanning methodHorizontal scan, synchronizedsensor and secondary slot motion	Scanning methodHorizontal scan, synchronizedsensor and secondary slot motion
	Scanning time8 - 10s	Scanning time10 - 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.

StandardsNo.	StandardsOrganization	Standards Title	Date
60601-1	UL	Medical Electrical Equipment, Part 1: General Requirements forSafety, A1:1991/A2:1995	2003
60601-1-2	IEC	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests. A1:2004	2004
60601-1-3	IEC	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard:Radiation protection in diagnostic X-ray equipment	1994
60601-2-7	IEC	Medical electrical equipment - Part 2-7: Particular requirements forthe safety of high-voltage generators of diagnostic X-ray generators	1998
60601-2-28	IEC	Medical electrical equipment - Part 2-28: Particular requirementsfor the basic safety and essential performance of X-ray tubeassemblies for medical diagnosis	1993
60601-2-32	IEC	Medical electrical equipment - Part 2: Particular requirements forthe safety of associated equipment of X-ray equipment	1994
60825-1	IEC	Safety of laser products - Part 1: Equipment classification andrequirements	2007
61223-3-4	IEC	Evaluation and routine testing in medical imaging departments -Part 3-4: Acceptance tests - Imaging performance of dental X-rayequipment	2000
62304	IEC	Medical device software - Software life cycle processes	2006
14971	ISO	Medical devices - Application of risk management to medicaldevices	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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

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

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
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.(b)
Classification. Class II.