Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard X-ray imaging and image processing techniques like superimposition, with no mention of AI, ML, or related concepts.

Therapeutic

No.
The device is used for diagnostic imaging (producing X-ray images) and does not provide therapy or treatment.

Diagnostic

Yes

The device produces X-ray images and projections for dental radiographic examinations of teeth, jaw, and TMJ areas, which are used to aid in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is equipped with an X-ray generator, Sensor unit, Arm unit, Column unit, and Sliding body unit, which are all hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The IMAGEWORKS PANOURA is a dental radiographic device that uses X-rays to create images of teeth, jaw, and TMJ areas. It operates by irradiating the patient directly and detecting the absorbed X-rays.
No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's body to generate images.

Therefore, the function and operation of the IMAGEWORKS PANOURA fall under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMAGEWORKS PANOURA 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 of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

Product codes

MUH

Device Description

The IMAGEWORKS PANOURA is dental panoramic and cephalometric device and 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 of examined volume for the reconstruction of 3D view. The IMAGEWORKS PANOURA 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 IMAGEWORKS PANOURA 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

teeth, jaw and TMJ areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentists and other legally qualified professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification/validation, performance testing, and risk analysis were performed. In conclusion, those testing and analysis demonstrated that the IMAGEWORKS PANOURA did not raise any new safety or effectiveness concerns compared to the PANOURA 18S (K111231) and the ORTHOPANTOMOGRAPH (K093683).
Bench tests regarding laser safety to ensure safety and effectiveness, verify conformity with IEC 60825-1.
EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC60601-1. IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111231, K093683

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Section 6- 510(k) Summary

MAR 0 8 2013

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 011-81- 3-3633-9420 Fax: Email: hi-watanabe@yoshida-net.co.jp

b. Contact/Application Correspondent

Izumi Maruo MIC International 4-1-17 Hongo, Bunkyo-ku Tokyo, 113-0033, Japan

011-81-3-3818-8577 Phone: Fax: 011-81-3-3818-8573 Email: maruo@mici.co.jp

ﻦ Date prepared

September 5, 2012

d. Name of device

Trade Name:	IMAGE WORKS PANOURA
Common Name:	Extraoral source x-ray system
Classification Name:	System, x-ray, extraoral source, digital
Classification Regulation:	21 CFR 872.1800

THE YOSHIDA DENTAL MFG. CO., LTD. SEPTEMBER 5, 2012

SECTION 6 6- 2 OF 6-9

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·· e. Predicate devices

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

510(k):	K111231
Trade name:	PANOURA 18S
Product code:	MUH

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

The predicate devices are hereinafter called "the PANOURA 18S (K111231)" or "the ORTHOPANTOMOGRAPH (K093683)" , respectively, in this application.

f. Description of the device

The IMAGEWORKS PANOURA is dental panoramic and cephalometric device and 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 of examined volume for the reconstruction of 3D view. The IMAGEWORKS PANOURA 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 IMAGEWORKS PANOURA 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. Statement of Intended Use

The IMAGEWORKS PANOURA 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 of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

h. Statement of substantial equivalence

The IMAGEWORKS PANOURA is modified from the PANOURA 18S (K111231) by adding 3D imaging. The characteristics except 3D imaging of the IMAGEWORKS PANOURA are identical to those of the PANOURA 18S (K111231).

Regarding intended use of the IMAGEWORKS PANOURA, 3D imaging is added to intended use of the PANOURA 18S (K111231). However, patient population and the fundamental technologies of the IMAGEWORKS PANOURA are identical to those of the PANOURA 18S (K111231).

3D imaging of the IMAGEWORKS PANOURA is similar to that of the ORTHOPANTOMOGRAPH (K093683). 3D image is produced by reconstruction of X-ray projection images. Intended Use of the IMAGEWORKS PANOURA is similar to that of the ORTHOPANTOMOGRAPH

THE YOSHIDA DENTAL MFG. CO., LTD. SEPTEMBER 5, 2012

SECTION 6 6- 3 OF 6-9

2

(K093683) because the characteristics of the IMAGEWORKS PANOURA are similar to the y ORTHOPANTOMOGRAPH (K093683). The similarities of the IMAGEWORKS PANOURA to the ORTHOPANTOMOGRAPH (K093683) are;

Intended use ●
ب ته دارات م
Operational characteristics .
. lonizing radiation
Cephalometric radiogram .
Panoramic images .
. 3D Imaging

In order to evaluate safety and effectiveness of the IMAGEWORKS PANOURA, software verification/validation, performance testing, and risk analysis were performed. In conclusion, those testing and analysis demonstrated that the IMAGEWORKS PANOURA did not raise any new safety or effectiveness concerns compared to the PANOURA 18S (K111231) and the ORTHOPANTOMOGRAPH (K093683).

i. Comparison table

Table 6-1. compares the characteristics between the IMAGEWORKS PANOURA, the PANOURA 18S (K111231), and the ORTHOPANTOMOGRAPH (K093683).

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| | IMAGEWORKS PANOURA
PREMARKET NOTIFICATION 510(k)
Table 6-1. Comparison Table | IMAGEWORKS PANOURA | PANOURA 18S (K111231) | ORTHOPANTOMOGRAPH (K093683) | |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device Characteristics | | | | | |
| Intended Use | | The IMAGEWORKS PANOURA 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 of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals. | 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. | The Orthopantomograph OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray 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 of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals. | |
| Equipment type | | Digital panoramic x-ray equipment | Digital panoramic x-ray equipment | Digital panoramic x-ray equipment | |
| Mode of operation | | Continuous operation with intermittent load | 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 | 0.5 mm×0.5 mm | |
| X-ray tube cooling method | | Oil cooling | Oil cooling | Oil cooling | |
| Nominal maximum electric power
(combination of X-ray tube voltage
and tube current at maximum output) | | 0.82kW (82kV, 10mA) | 0.82kW (82kV, 10mA) | 1.44kW (90kV, 16mA) | |
| Tube voltage | | 58 - 82kV | 58 - 82kV | 57 - 90kV | |
| Tube current | | 2.0 - 10mA | 2.0 - 10mA | 4 - 16mA | |
| Radiation time | | Adult | | | |
| | | Panoramic | 8, 14, 16s | 8, 14, 16s | 16.4s |
| | | Child | 6.4, 11.2, 12.8s | 6.4, 11.2, 12.8s | 14.4s |
| | | TMJ | 8s | 8s | 10.6s |
| | | Cephalo / Carpus image acquisition | 8 - 10 s | 8 - 10 s | 10-20s |

THE YOSHIDA DENTAL MFG. CO., LTD
SEPTEMBER 5, 2012

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6- 5 OF 6-9

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| IMAGEWORKS PANOURA
PREMARKET NOTIFICATION 510(k)

Device Characteristics		3D oral	3D	3D dent		PANOURA 18S (K111231)	ORTHOPANTOMOGRAPH (K093683)
Radiation time		11.5s x 2		11.5s	Electric power supply resistance	Maximum 0.2 Ω	Small FOV standard resolution: 2.3 s
Large FOV standard resolution: 4.9s
Small FOV high resolution: 6.1 s
Large FOV high resolution: 12.6 s
Total filtration						Maximum 0.2 Ω
2.5mmAl equivalent or over				Maximum 0.2 Ω
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
Image magnification			Panoramic			1.2 to 1.29	1.3
			TMJ			1.2 to 1.29	1.23
			Cephalo			1.1	1.14
			3D			1.0	1.0
Number of phases						Single phase	Single phase
Frequency						50/60 Hz	50/60Hz
Rated power	Voltage					AC100V-120V / AC220V - 240V	AC100 - 240V (Selectable)
Input	110VAC	2.0kVA				AC100V-120V / AC220V - 240V
2.0kVA				1.65kVA
	230VAC	2.0kVA				2.0kVA	2.3kVA
Classification						Class I, Type B	Class I, Type B
Up-and-down stroke						800 mm (short type: 400 mm)	800 mm
Weight						140kg Standing position, wall mount
(with 3D detector)
135kg Standing position, wall mount
(short type) (with 3D detector)
165 kg Standing position, base
mount with an optional base (in the
case of wide base: +5kg) (with 3D
detector)
160kg Standing position, base mount
(short type) with an optional base (in
the case of wide base: +5kg) (with				125kg Standing position wall mount
120kg Standing position wall mount
(short type)
150 kg (with an optional base)
145kg Standing position base mount
short type with an optional base/ 150kg
with wide base				200kg (Panoramic)

THE YOSHIDA DENTAL MFG. CO., LTD.
SEPTEMBER 5, 2012

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6- 6 OF 6-9

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| | IMAGEWORKS PANOURA
PREMARKET NOTIFICATION 510(k) | | PANOURA 18S (K111231) | ORTHOPANTOMOGRAPH (K093683) |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Device Characteristics | | | | |
| | IMAGEWORKS PANOURA | | | |
| Weight | 180kg Standing position wall mount
(with Cephalo) | | 190kg Standing position wall mount
(with Cephalo) | 240kg (Cephalo) |
| | 175kg Standing position, base mount
(short type) (with Cephalo) (with 3D
detector) | | 185kg Standing position wall mount
short type (with Cephalo) | |
| | 205kg Standing position, base mount
with an optional base (with Cephalo)
(in the case of wide base: +5kg)
(with 3D detector) | | 215kg Standing position base mount
with Cephalo and optional base | |
| | 200kg Standing position, base mount
(short type) (with Cephalo) (in the
case of wide base: +5kg) (with 3D
detector) | | 210kg Standing position base mount
short type with Cephalo and optional
base/ 215kg with wide base | |
| Size | 2209 x 846 x 1192mm(Standing
position wall mount) | | 2209 x 849 x 1192mm(Standing
position wall mount) | 2410 x 830 x 1126mm (standard
column) |
| | 2209 x 1835 x 1192mm(Standing
position wall-mount with Cephalo) | | 2209 x 1759 x 1192mm(Standing
position wall-mount with Cephalo) | 2410 x 1931 x 1193 mm (with
Cephalo) |
| ID/SOD (Panoramic) | 485mm/350mm | | 485mm/350mm | 500mm(SID) |
| ID/SOD (Cephalo) | 1650mm/1500mm | | 1650mm/1500mm | 1745mm/1520mm |
| ID/SOD (3D) | 570mm/350mm | | | unknown |
| Operating
environment | Temperature | 10 to 40°C | 10 to 40°C | 10 to 35°C |
| | Relative humidity | 30 to 75% (no condensation) | 30 to 75% (no condensation) | max 85% |
| EMC Classification | | ClassA | ClassA | Class B |
| Target angle | | 15 degrees | 15 degrees | 5 degrees |
| Positioning laser lights | | laser light (CLASS 2 LASER
PRODUCT) | laser light (CLASS 2 LASER
PRODUCT) | laser light (CLASS 1 LASER
PRODUCT) |
| | | IEC
60825-1:1993+A1:1997+A2:2001 | IEC 60825-1:1993+A1:1997+A2:2001 | IEC
60825-1:1993+A1:1997+A2:2001 |
| Cephalometric
radiogram | Scanning method | Horizontal scan, synchronized
sensor and secondary slot motion | Horizontal scan, synchronized
sensor and secondary slot motion | Horizontal scan, synchronized
sensor and secondary slot motion |
| | Scanning time | 8-10s | 8-10s | 10-20s |
| Panoramic
image receptor | Sensor unit | Pan sensor or interchangeable
Cephalo sensor | Pan sensor or interchangeable Cephalo
sensor | Pan sensor or interchangeable
Cephalo sensor |
| | Technology | CMOS | CMOS | CMOS |

THE YOSHIDA DENTAL MFG. CO., LTD
SEPTEMBER 5, 2012

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| | IMAGEWORKS PANOURA
PREMARKET NOTIFICATION 510(k) | IMAGEWORKS PANOURA | PANOURA-18S (K111231) | ORTHOPANTOMOGRAPH (K093683) |
|---------------------------------|-----------------------------------------------------|--------------------------------|--------------------------------|----------------------------------|
| Device Characteristics | | | | |
| Panoramic
Image receptor | Image pixel size | 100 x 100 μm | 100 x 100 μm | 100 x 100 μm |
| | Image field height | 151mm / 1510pixels | 151mm / 1510pixels | 151mm / 1480pixels |
| | Sensor unit | interchangeable Cephalo sensor | interchangeable Cephalo sensor | interchangeable Cephalo sensor |
| | Technology | CMOS | CMOS | CMOS |
| Cephalometric
Image receptor | Image pixel size | 100 x 100 μm | 100 x 100 μm | 100 x 100 μm |
| | Image field height | 226.6mm / 2266pixels | 226.6mm / 2266pixels | 226mm / 2232pixels |
| | Image field width in
LA view | 254mm | 254mm | 260mm, maximum
170mm, minimum |
| | Image field width
in PA view | 203.2mm | 203.2mm | 200mm |
| | Sensor unit | - | - | 3D sensor |
| | Technology | - | - | CMOS |
| 3D image receptor | Image pixel size | 100 x 100 μm | - | 200μm |
| | Image field height | 99.2mm / 992pixels | - | 61 mm |

THE YOSHIDA DENTAL MFG. CO., LT
SEPTEMBER 5, 2012

SECTION 6

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Risk Analysis ... j.

The IMAGEWORKS PANOURA was evaluated in accordance with ISO14971:2007. The risk management of the device was deemed satisfactory.

k. Bench Testing

THE YOSHIDA DENTAL MFG. CO., LTD has performed bench tests regarding laser safety to ensure safety and effectiveness, verify conformity with IEC 60825-1.

The laser system of the IMAGEWORKS PANOURA is identical to that of the PANOURA 18S (K111231). Therefore, the test report for IEC 60825-1 for the PANOURA 18S (K111231) is used as the test report for the IMAGEWORKS PANOURA.

The software of the IMAGEWORKS PANOURA has been validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

EMC, Electric safety, and X-ray radiation safety are confirmed in accordance with IEC60601-1. IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32.

ﺎﺕ Conclusion

The IMAGEWORKS PANOURA is modified from the PANOURA 18S (K111231) by adding 3D imaging. The characteristics except 3D imaging of the IMAGEWORKS PANOURA are identical to those of the PANOURA 18S (K111231). The IMAGEWORKS PANOURA has similar intended use and operational and technological characteristics to the ORTHOPANTOMOGRAPH (K093683). The performance test results indicate that the IMAGEWORKS PANOURA meets the requirements of recognized consensus or voluntary standard. Based on the information presented above regarding substantial equivalence to the PANOURA 18S (K111231) and the ORTHOPANTOMOGRAPH (K093683), THE YOSHIDA DENTAL MFG CO., LTD. concludes that the IMAGEWORKS PANOURA is substantially equivalent to the PANOURA 18S (K111231) and the ORTHOPANTOMOGRAPH (K093683), and does not raise any new questions regarding safety or effectiveness.

THE YOSHIDA DENTAL MFG. CO., LTD. SEPTEMBER 5, 2012

SECTION 6 6- 9 OF 6-9

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows a circular logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an eagle-like figure with outstretched wings, rendered in a bold, black design. The emblem is a simplified representation, focusing on the wing structure and overall form rather than detailed features.

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

March 8, 2013

Ms. Izumi Maruo MIC International 4-1-17 Hongo, Bunkyo-ku TOKYO 113-0033 JAPAN

Re: K122806

Trade/Device Name: ImageWorks Panoura Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 25, 2013 Received: March 1, 2013

Dear Ms. Maruo:

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, isting 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 lo contract to contract mability

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 (7) & FR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

9

Page 2-Ms. Maruo

i 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

MichFDA Hara.

for

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

Enclosure

10

Indications for Use

510(k) Number (if known): K122806

Device Name: IMAGEWORKS PANOURA

Indications for Use:

The IMAGEWORKS PANOURA 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 of examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

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)

MichaELON'Hara

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

510(k) K122806

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