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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding reported performance for the new device (IMAGEWORKS PANOURA) in relation to its functionalities. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is largely implied by the statement that the characteristics (except 3D imaging) are identical to PANOURA 18S, and the 3D imaging is similar to ORTHOPANTOMOGRAPH.

The closest we get to "acceptance criteria" are the characteristics presented in the comparison table (Table 6-1) and the mention of conformity to recognized standards.

Implicit Acceptance Criteria (based on predicate device characteristics and standards conformity):

Feature/Criterion	IMAGEWORKS PANOURA Performance (Implied)
Intended Use	Dental radiographic examinations of teeth, jaw, and TMJ areas, producing conventional 2D X-ray images and X-ray projection images for 3D reconstruction. Operated by dentists/qualified professionals. (Matches predicate devices, specifically similar to ORTHOPANTOMOGRAPH for 3D).
Equipment Type	Digital panoramic x-ray equipment (Matches predicate devices).
Mode of Operation	Continuous operation with intermittent load (Matches predicate devices).
X-ray Tube Focal Point	0.5 mm x 0.5 mm (Matches predicate devices).
X-ray Tube Cooling	Oil cooling (Matches predicate devices).
Nominal Max. Electric Power	0.82kW (82kV, 10mA) (Matches PANOURA 18S, but lower than ORTHOPANTOMOGRAPH's 1.44kW, 90kV, 16mA. This difference is not presented as a failure of acceptance criteria, implying it's within acceptable dental radiography ranges).
Tube Voltage	58 - 82kV (Matches PANOURA 18S, narrower range than ORTHOPANTOMOGRAPH's 57 - 90kV).
Tube Current	2.0 - 10mA (Matches PANOURA 18S, narrower range than ORTHOPANTOMOGRAPH's 4 - 16mA).
Radiation Time (Panoramic)	Adult (8, 14, 16s), Child (6.4, 11.2, 12.8s), TMJ (8s) (Matches PANOURA 18S, some differences from ORTHOPANTOMOGRAPH's 16.4s, 14.4s, 10.6s respectively).
Radiation Time (Cephalo/Carpus)	8-10s (Matches PANOURA 18S, some differences from ORTHOPANTOMOGRAPH's 10-20s).
Radiation Time (3D)	11.5s x 2 (3D oral), 11.5s (3D dent) (Different from ORTHOPANTOMOGRAPH's ranges for different FOVs and resolutions, but not presented as a failure).
Total Filtration	2.5mmAl equivalent or over (Matches PANOURA 18S, slightly lower than ORTHOPANTOMOGRAPH's 3.2mm Al equivalent or over. This is likely acceptable given the context and regulatory limits).
Leakage Dose	1.0 mGy/h or less (Matches predicate devices).
Image Magnification (Panoramic)	1.2 to 1.29 (Matches PANOURA 18S, similar to ORTHOPANTOMOGRAPH's 1.3).
Image Magnification (TMJ)	1.2 to 1.29 (Matches PANOURA 18S, similar to ORTHOPANTOMOGRAPH's 1.23).
Image Magnification (Cephalo)	1.1 (Matches PANOURA 18S, similar to ORTHOPANTOMOGRAPH's 1.14).
Image Magnification (3D)	1.0 (Matches ORTHOPANTOMOGRAPH).
EMC Classification	Class A (Matches PANOURA 18S, but differs from ORTHOPANTOMOGRAPH's Class B. This difference is accepted, implying compliance with Class A standards is sufficient).
Panoramic Image Pixel Size	100 x 100 µm (Matches predicate devices).
Cephalometric Image Pixel Size	100 x 100 µm (Matches predicate devices).
3D Image Pixel Size	100 x 100 µm (Differs from ORTHOPANTOMOGRAPH's 200 µm. This is an improvement and is presented as acceptable).
Software Validation	Validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Conformance asserted).
Safety Standards	Complies with IEC 60825-1 (laser safety for IMAGEWORKS PANOURA, by referencing predicate's report), 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 (EMC, Electric safety, X-ray radiation safety). (Conformance asserted).
Risk Assessment	Evaluated in accordance with ISO14971:2007, deemed satisfactory. (Conformance asserted).

Summary of the "Study" (Demonstration of Substantial Equivalence):

The submission does not detail a traditional "study" in the sense of a clinical trial or a performance benchmark against specific, pre-defined quantitative metrics for the new features like 3D imaging. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

The "study" comprises the following:

Comparison to Predicate Devices: The primary method is a detailed comparison of the IMAGEWORKS PANOURA's characteristics (both 2D and 3D) to two predicate devices:
- PANOURA 18S (K111231): The new device is stated to be a modification of this predicate, with identical characteristics except for the addition of 3D imaging.
- ORTHOPANTOMOGRAPH OP300 (K093683): The 3D imaging functionality of the new device is explicitly compared to this predicate, cited as having similar intended use, operational characteristics, ionizing radiation, cephalometric radiograms, panoramic images, and 3D imaging.
Bench Testing:
- Laser Safety: Bench tests for laser safety were performed to ensure conformity with IEC 60825-1. For the IMAGEWORKS PANOURA, the test report from the identical laser system of the PANOURA 18S (K111231) was used.
- Software Validation: The software was validated according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- EMC, Electrical Safety, X-ray Radiation Safety: Conformance 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 was confirmed through bench testing.
Risk Analysis: The device underwent risk evaluation in accordance with ISO14971:2007, and the risk management was deemed satisfactory.

The conclusion is that these tests and analyses demonstrated that the IMAGEWORKS PANOURA did not raise any new safety or effectiveness concerns compared to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There is no mention of a "test set" of clinical images or patient data used for evaluating diagnostic performance in a quantitative manner. The device is an X-ray imaging system, and the evaluation focuses on its technical specifications, safety, and operational equivalence.
Data Provenance: Not applicable. The evaluation is based on device specifications, engineering tests, and comparison to existing, legally marketed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Experts and Qualifications: Not applicable. No "ground truth" for diagnostic performance on a test set is established or reported for this submission. The assessment is of the physical device and its technical compliance.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no test set or expert evaluation of diagnostic performance requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device characteristics and safety, not on the diagnostic accuracy of human readers using the device's images, nor on the improvement with AI assistance (as this is an imaging device, not an AI diagnostic tool).

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: Not applicable. This document describes an X-ray imaging device, not a standalone algorithm. Its performance is inherent in its hardware, software, and physical characteristics.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable for diagnostic performance. For the device itself, the "ground truth" for proving safety and effectiveness are established engineering standards, regulatory guidelines (e.g., IEC standards, ISO 14971), and the technical specifications and clinical performance records of the predicate devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI algorithm requiring a training set of images. The "software validation" mentioned refers to the development and testing of the device's control and image processing software, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm. The software validation would have involved established software development and testing methodologies, comparing output to expected logic and specifications.

Summary

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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

g. Statement of Intended Use

h. Statement of substantial equivalence

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

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(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).

SECTION 6 6- 4 OF 6-9

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	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 voltageand 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

SECTION 6

6- 5 OF 6-9

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IMAGEWORKS PANOURAPREMARKET 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 sLarge FOV standard resolution: 4.9sSmall FOV high resolution: 6.1 sLarge FOV high resolution: 12.6 s
Total filtration						Maximum 0.2 Ω2.5mmAl equivalent or over	Maximum 0.2 Ω3.2mm 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 - 240V2.0kVA	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, basemount with an optional base (in thecase of wide base: +5kg) (with 3Ddetector)160kg Standing position, base mount(short type) with an optional base (inthe case of wide base: +5kg) (with	125kg Standing position wall mount120kg Standing position wall mount(short type)150 kg (with an optional base)145kg Standing position base mountshort type with an optional base/ 150kgwith wide base	200kg (Panoramic)

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

SECTION 6
6- 6 OF 6-9

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	IMAGEWORKS PANOURAPREMARKET 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 3Ddetector)		185kg Standing position wall mountshort type (with Cephalo)
	205kg Standing position, base mountwith an optional base (with Cephalo)(in the case of wide base: +5kg)(with 3D detector)		215kg Standing position base mountwith Cephalo and optional base
	200kg Standing position, base mount(short type) (with Cephalo) (in thecase of wide base: +5kg) (with 3Ddetector)		210kg Standing position base mountshort type with Cephalo and optionalbase/ 215kg with wide base
Size	2209 x 846 x 1192mm(Standingposition wall mount)		2209 x 849 x 1192mm(Standingposition wall mount)	2410 x 830 x 1126mm (standardcolumn)
	2209 x 1835 x 1192mm(Standingposition wall-mount with Cephalo)		2209 x 1759 x 1192mm(Standingposition wall-mount with Cephalo)	2410 x 1931 x 1193 mm (withCephalo)
ID/SOD (Panoramic)	485mm/350mm		485mm/350mm	500mm(SID)
ID/SOD (Cephalo)	1650mm/1500mm		1650mm/1500mm	1745mm/1520mm
ID/SOD (3D)	570mm/350mm			unknown
Operatingenvironment	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 LASERPRODUCT)	laser light (CLASS 2 LASERPRODUCT)	laser light (CLASS 1 LASERPRODUCT)
		IEC60825-1:1993+A1:1997+A2:2001	IEC 60825-1:1993+A1:1997+A2:2001	IEC60825-1:1993+A1:1997+A2:2001
Cephalometricradiogram	Scanning method	Horizontal scan, synchronizedsensor and secondary slot motion	Horizontal scan, synchronizedsensor and secondary slot motion	Horizontal scan, synchronizedsensor and secondary slot motion
	Scanning time	8-10s	8-10s	10-20s
Panoramicimage receptor	Sensor unit	Pan sensor or interchangeableCephalo sensor	Pan sensor or interchangeable Cephalosensor	Pan sensor or interchangeableCephalo sensor
	Technology	CMOS	CMOS	CMOS

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

SECTION 6
6- 7 OF 6-9

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	IMAGEWORKS PANOURAPREMARKET NOTIFICATION 510(k)	IMAGEWORKS PANOURA	PANOURA-18S (K111231)	ORTHOPANTOMOGRAPH (K093683)
Device Characteristics
PanoramicImage 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
CephalometricImage 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 inLA view	254mm	254mm	260mm, maximum170mm, minimum
	Image field widthin 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

6- 8 OF 6-9

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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

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Indications for Use

510(k) Number (if known): K122806

Device Name: IMAGEWORKS PANOURA

Indications for Use:

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

Page 1 of 1

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.