PHT-6500 (PHT-60CFO) is a computed tomography x-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of x-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry . The device is operated and used by physicians, dentists, and x-ray technicians.

Device Description

PHT-6500 (PHT-60CFO), a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometire and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, PHT-6500 (PHT-60CFO) is a complete dental X-ray system equipped with x-ray tube, generator and dedicated SSXI detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on CMOS digital X-ray detector. CMOS CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental x-ray system based on CMOS X-ray detector. The proposed device is available with two X-ray generator options.

A pair of CT sensor and Pano sensor are assembled together, back to back, and fixed mechanically to the rotating X-ray gantry, facing the X-ray tube from the opposite side. Based on the choice of a modality, between CT and panorama, the mechanically attached sensors rotate automatically so an appropriate type of sensor is facing the X-ray tube for exposure.
The type of CT sensor attached to the equipment determines the model name. The model name, PHT-6500, refers to the equipment mounted with Xmaru0712CF, and Xmaru1215CF Plus SSXI detector whereas PHT- 60 CFO model refers to the equipment mounted with Xmaru1215CF Master Plus and Xmaru1524CF Master Plus SSXI detector.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PHT-6500 (PHT-60CFO) dental computed tomography X-ray system:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a Special 510(k) submission, which means the device is an upgraded version of a legally marketed predicate device with the same indications for use and technical characteristics. Therefore, the primary "acceptance criterion" is proving substantial equivalence to the predicate device (K122606). The performance testing focuses on demonstrating that the new components or changes do not negatively impact safety or effectiveness, and in some cases, show improvement or equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (K122606)	The new device is stated to be "identical to the predicate device in its indications for use, performance, materials, safety characteristics, image viewing program and accessory components." (Page 5)
Technological Characteristics	"The fundamental technological characteristics of the subject and predicate device were the same." (Page 5)
Safety (IEC Standards Compliance)	Safety tests were conducted for each generator according to IEC standards (IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -2-44). "All test results were satisfactory." (Page 6-7)
EMC (IEC Standard Compliance)	EMC testing conducted in accordance with IEC 60601-1-2. "All test results were satisfactory." (Page 6-7)
Radiation Control (CFR Standards Compliance)	Manufacturing facility conforms with 21 CFR 1020.30, 31, and 33. (Page 6)
Image Quality (MTF, DQE, NPS) for New Detectors	"Based on the Non-Clinical Test results, even though the pixel size and active area of the new SSXI detectors are different, the diagnostic image quality of new sensors is equal or better than that of the predicate device and there is no significant difference in efficiency and safety." (Page 6)
CT Image Evaluation (IEC Standards Compliance)	Acceptance test and CT image evaluation report performed according to IEC 61223-3-4 and IEC 61223-3-5. (Page 7)
Clinical Image Evaluation (for each X-ray generator)	"A separate clinical image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the performance of a radiographic imaging device." (Page 7). "A separate image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the quality of radiographic images and imaging performance of the device." (Page 6)
DICOM Conformance	Meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. DICOM Conformance Statement unchanged from predicate. (Page 6-7)
Biocompatibility	Biocompatibility evaluation report identical to predicate device. (Page 7)
Image Viewing Software Validation	Image viewing SW validation reports identical to predicate device. (Page 7)

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

The document does not explicitly state a specific human "test set" sample size or data provenance (country of origin, retrospective/prospective) in the context of clinical performance evaluation directly. The emphasis is on non-clinical testing and expert evaluation of images.

Non-clinical testing: This involved evaluating physical characteristics like MTF, DQE, and NPS for the new detectors and X-ray generators. No patient data is typically involved in these tests.
Clinical image evaluation: This was "performed for each X-ray generator" (Page 6, 7), but the number of cases or patients, or their origin, is not specified. Given the nature of a Special 510(k) and the statement about "no significant difference in efficiency and safety," it's likely this involved expert review of a limited set of images rather than a large-scale clinical trial with a defined patient cohort.

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

The document mentions "qualified individuals employed by the sponsor" evaluating laboratory and clinical performance testing (Page 5), and "a separate clinical image evaluation is performed for each X-ray generator" (Page 7). However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any clinical image evaluations. Given the focus on demonstrating equivalence and the lack of detail on reader studies, it's highly probable that a formal, multi-reader adjudication process as seen in AI efficacy studies was not conducted or deemed necessary for this Special 510(k).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the provided text. The document refers to clinical image evaluations to assess the X-ray generator's effect on image quality, but it does not describe a study comparing human readers with and without AI assistance or any other comparative effectiveness study. This type of study is more common for devices claiming enhanced diagnostic performance or AI integration, which is not the primary focus of this Special 510(k) (which focuses on an upgraded version of an existing device).

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

This device is an X-ray imaging system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance like in AI devices does not apply in the same way. The performance is intrinsically linked to the hardware generating the images. The non-clinical tests (MTF, DQE, NPS) could be considered "standalone" in that they evaluate the physical imaging components themselves, separate from a human interpreter.

7. The Type of Ground Truth Used:

For the non-clinical tests (MTF, DQE, NPS), the "ground truth" would be objective physical measurements and established engineering standards.

For the "clinical image evaluation," the ground truth is most likely based on expert consensus/opinion regarding diagnostic image quality, comparing images from the upgraded device to those from the predicate device or a reference standard, to ensure no degradation in diagnostic utility. The document's statement about "diagnostic image quality of new sensors is equal or better" (Page 6) suggests this. There is no mention of pathology or outcomes data being used for ground truth.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this submission is for an upgraded X-ray hardware system, there is no mention of a training set in the context of AI model development.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set for an AI algorithm, this question is not applicable to the provided document.

Summary

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K130432
page 1 of 8

510(k) Submission – PHT-6500 (PHT-60CFO)

Special 510(k) Summary

MAY 3 1 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510K summary prepared: February 15th, 2013

Submitter's Name, address, telephone number, a contact person:

Submitter's Name : Submitter's Address: Vatech Co., Ltd. 23-4, Seogu-Dong, Hwaseong-Si, Gyeonggi-Do. 445-170. Republic of Korea

Submitter's Telephone: Contact person:

+82-31-379-9585 Mr. Sung-Hee Park

Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
(U.S. Designated agent)
Address:	12946 Kimberley Ln, Houston, TX 77079
Telephone:	+713-467-2607
Fax:	+713-464-8880

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

Trade/Proprietary Name:	PHT-6500 (PHT-60CFO)
Common Name:	Dental Computed Tomography X-ray System
Classification Name:	System. X-ray, Tomography, Computed , Dental (21CFR 892.1750,Class II)
Product Code:	OAS

Vatech Co., Ltd.

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Predicate Device:

Manufacturer:	Vatech Co., Ltd
Device Name:	PHT-6500 (PHT-60CFO)
510(k) Number:	K122606

Device Description:

A pair of CT sensor and Pano sensor are assembled together, back to back, and fixed mechanically to the rotating X-ray gantry, facing the X-ray tube from the opposite side. Based on the choice of a modality, between CT and panorama, the mechanically attached sensors rotate automatically so an appropriate type of sensor is facing the X-ray tube for exposure.
The type of CT sensor attached to the equipment determines the model name. The model name, PHT-6500, refers to the equipment mounted with Xmaru0712CF, and Xmaru1215CF Plus SSXI detector whereas PHT- 60 CFO model refers to the equipment mounted with Xmaru1215CF Master Plus and Xmaru1524CF Master Plus SSXI detector.

Indication for use:

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510(k) Submission – PHT-6500 (PHT-60CFO)

rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and x-ray technicians.

Summary of the technological characteristics of the device compared to the predicate device:

The new device described in this special 510(k) submission is an upgraded version of the predicate device with the same model name, the same indications for use and technical characteristics. Table 1 summarizes the technological characteristics of the new vs. the predicate device.

Characteristic	ProposedVatech Co., Ltd.PHT-6500 (PHT-60CFO)	PredicateVatech Co., Ltd.PHT-6500 (K122606)
510(k) number		K122606
Indicationsfor use	PHT-6500 (PHT-60CFO) is acomputed tomography x-raysystem intended to producepanoramic, cephalometric orcross-sectional images of theoral anatomy on a real time basisby computer reconstruction of x-ray image data from the sameaxial plane taken at differentangles. It provides diagnosticdetails of the anatomic structuresby acquiring 360° rotationalimage sequences of oral andmaxillofacial area for a precisetreatment planning in adult andpediatric dentistry . The deviceis operated and used byphysicians, dentists, and x-raytechnicians.	PHT-6500 (PHT-60CFO) is acomputed tomography x-raysystem intended to producepanoramic, cephalometric orcross-sectional images of theoral anatomy on a real time basisby computer reconstruction of x-ray image data from the sameaxial plane taken at differentangles. It provides diagnosticdetails of the anatomic structuresby acquiring 360° rotationalimage sequences of oral andmaxillofacial area for a precisetreatment planning in adult andpediatric dentistry . The deviceis operated and used byphysicians, dentists, and x-raytechnicians.
PerformanceSpecification	Panoramic, cephalometric andcomputed tomography	Panoramic, cephalometric andcomputed tomography
Input Voltage	AC 100-240 V	AC 100-120/200-240 V
Tube Voltage	50-99 kV	50-90 kV
Tube Current	4~16 mA	4~10 mA
Exposure Time	0.7 - 24 s	0.7 - 24 s
X-ray Source	D-052SBOPX/105	D-052SB
X-ray Generator	DG-07C11T2 (for D-052SB)DG-07C11C1 (for OPX/105)	HDG-07B10T2
Focal Spot Size	0.5 mm	0.5 mm
Slice Width	0.1 mm min.	0.1 mm min.
Total Filtration	2.8 mmAl	2.8 mmAl
Chin Rest	Equipped Headrest	Equipped Headrest
PerformanceSpecification	Computed tomography	Computed tomography
Mechanical	Compact design	Compact design
Electrical	LDCP logic circuit	LDCP logic circuit
Software	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
2D Image ViewingProgram	EasyDent	EasyDent
3D Image ViewingProgram	Ez3D Plus	Ez3D Plus
Anatomical Sites	Maxillofacial	Maxillofacial
Image Receptor	ComputedTomography(Flat PanelDetector)Xmaru0712CFXmaru1215CF PlusXmaru1215CFMaster PlusXmaru1524CFMaster Plus	Xmaru0712CFXmaru1215CF PlusXmaru1215CFMaster Plus-
	Panoramic(CMOSphotodiode array)Xmaru1501CF	Xmaru1501CF
	CephaloMetric(CMOSphotodiodearray)Scan TypeXmaru2301CFXmaru3001CF	Xmaru2301CF-
	One Shot Type1210SGA	1210SGA
	910SGA	910SGA
	1417PGA	-
Size of Active	Xmaru0712CFMax. 8 x 8 cm	Max. 8 x 8 cm

Table 1. Comparison of new PHT-6500 (PHT-60CFO) and the predicate device

Vatech Co., Ltd.

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510(k) Submission – PH T -6500 (PHT -60C F O )

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510(k) Submission – PHT-6500 (PHT-60CFO)

Imaging Area		Xmaru1215CFPlus	Max. 12 x 9 cm	Max. 12 x 9 cm
ﺗ		Xmaru1215CFMuster Plus	Max. 10 x 8 cm	Max. 12 x 9 cm
		Xmaru1524CFMaster Plus	Max. 16 x 10 cm	-
		Xmaru1501CF	150.4 x 6 mm	150.4 x 6 mm
		Xmaru2301CF	230.4 x 5.9 mm	230.4 x 5.9 mm
		Xmaru3001CF	307.2 x 5.9 mm
		910SGA	260 x 227 mm	260 x 227 mm
		1210SGA	325 x 264 mm	325 x 264 mm
		1417PGA	422.7 x 357.6 mm
		Xmaru0712CF	3.5 lp/mm	3.5 lp/mm
Pixel	CT	Xmaru1215CFPlus	3.5 lp/mm	3.5 lp/mm
		Xmaru1215CFMaster Plus	5.0 lp/mm - 2x2binning	5.0 lp/mm - 2x2binning2.5 lp/mm - 4x4binning
		Xmaru1524CFMaster Plus	5.0 lp/mm - 2x2binning	-
Resolution	Pano	Xmaru1501CF	5 lp/mm	5 lp/mm
	Ceph	Xmaru2301CF	5 lp/mm	5 lp/mm
		Xmaru3001CF	5 lp/mm	-
		1210SGA	3.9 lp/mm	3.9 lp/mm
		910SGA	3.9 lp/mm	3.9 lp/mm
		1417PGA	3.9 lp/mm	1
Pixel Size	CT	Xmaru0712CF	140 x 140 um	140 x 140 mm
		Xmaru1215CFPlus	140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x 140 x	140 x 140 xm
		Xmaru1215CFMaster Plus	99 mm - 2x2 binning	99 um - 2x2 binning198 mm - 4x4 binning
		Xmaru1524CFMuster Plus	99 um - 2x2 binning	1
Pano	Xmaru1501CF	100 x 100 xam	100 x 100 um
Ceph	Xmaru2301CF	100 x 100 xm	100 x 100 um
	Xmaru3001CF	100 x 100 um
	1210SGA	127 x 127 xan	127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x
	910SGA	127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x 127 x	127 x 127 um
	1417PGA	127 x 127 x 127 x 127 x 127 x 127 x 127 x 127

Vatech Co., Ltd.

・・

ﺮ

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510(k) Submission – PHT -6500 (PHT -60C FO)

Summary of Performance Testing:

The PHT-6500 (PHT-60CFO) dental computed tomography X-ray system described in this special 510(k) is identical to the predicate device in its indications for use, performance, materials, safety characteristics, image viewing program and accessory components

Furthermore, the following information further substantiates the substantial equivalence between two devices:

. The fundamental technological characteristics of the subject and predicate device were the same.
Laboratory and clinical performance testing using the same test protocols as . used for the cleared detectors was evaluated by qualified individuals employed by the sponsor to demonstrate that adequate design controls (according to 21 CFR 820.30) were in place.
The intended use of the modified device, as described in the labeling, has not . changed as a result of the labeling modification(s).

For both devices, the differences are as follows.

1. New SSXI detectors, Xmarul 524CF Master Plus (CBCT mode), 1417PGA (One Shot Ceph mode) and Xmaru3001CF (Scan Ceph mode) for the newly upgraded PHT-6500 (PHT-60CFO} have different active areas compared with K122606, the predicate device.
1. Change to Free Input Voltage: For the predicate device, changing the input voltage from I 10V to 200V would require separate tools and electrical works whereas the new device is equipped with a newly designed power board which is capable of handling the input power between 100 V and 240 V without a separate tool or electrical modification.
1. The proposed PHT-6500 is available with two different X-ray tube and generator options.

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510(k) Submission – PHT -6500 (PHT-60CFO)

To evaluate the safety, a series of safety tests are conducted for each generator according to the IEC Standard. Moreover, a separate image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the quality of radiographic images and imaging performance of the device. The maximum rating chart for each new X-ray tube and generator option is described in the Device Description (page. 19 ~ 20). The graph indicates the exposure time range for various voltage and current settings.

1. For proposed PHT-6500 (PHT-60CFO), a new generator for X-ray tube has the capacity to generate more tube current and tube voltage than the predicate device. Moreover, the maximum irradiation condition for each capture mode is defined differently by diversifying the operating range of the generator specifications.
  Non-clinical test and clinical consideration test were conducted for each new sensor of PHT-6500 (PHT-60CFO) compared with its predicate device with regard to Modulation Transfer Function (MTF), Detective Quantum Efficiency (DOE) and Noise to Power Spectrum (NPS). Based on the Non-Clinical Test results, even though the pixel size and active area of the new SSXI detectors are different, the diagnostic image quality of new sensors is equal or better than that of the predicate device and there is no significant difference in efficiency and safety.

Safety, EMC and Performance Data:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1(A1+A2, 1995), IEC 60601-1-1 (Ed. 2, 2000), IEC 60601-1-3 (Ed. 1, 1994), IEC 60601-2-7 (Ed. 2, 1998), IEC 60601-2-28 (Ed. 1, 1993), IEC 60601-2-32 (Ed. 1, 1994) and IEC 60601-2-44 (Ed. 2, 2002) were performed, and EMC testing were conducted in accordance with standard IEC 60601-1-2.

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.

PHT-6500 (PHT-60CFO) meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set.

Non-clinical & Clinical considerations according to FDA Guidance "Guidance for

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K130432
Page 8 of 8

510(k) Submission – PHT -6500 (PHT -60CFO)

the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed for the newly proposed device. A separate clinical image evaluation is performed for each X-ray generator which is considered as one of critical components affecting the performance of a radiographic imaging device.

Acceptance test and CT image evaluation report according to IEC 61223-3-4 and IEC 61223-3-5 were performed. A separate imaging evaluation is performed for each X-ray generator which is considered as one of critical components affecting the performance of a radiographic imaging device.

DICOM Conformance Statement, image viewing SW validation reports, biocompatibility evaluation report of the newly proposed device are identical to those of the predicate device. The newly proposed device also shares identical Xray detectors with the predicate device. Therefore, DICOM conformance statement, biocompatibility evaluation report, image viewing SW validation reports and the non-clinical consideration report for detectors same between the proposed and predicate device are not included in this submission.

All test results were satisfactory.

Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Vatech Co., Ltd. concludes that the newly upgraded PHT-6500 (PHT-60CFO) is safe and effective and substantially equivalent to predicate device as described herein.

END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

May 31, 2013

VaTech Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group l 2946 Kimberley Lane HOUSTON TX 77079

Re: K130432

Trade/Device Name: PHT-6500 (PHT-60CFO) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 6, 2013 Received: May 9, 2013

Dear Mr. Kim:

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. Ilsting 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.

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Page 2 - Mr. Kim

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Smh7)

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): K130432

Device Name: PHT-6500 (PHT-60CFO)

Indications for Use:

Prescription Use (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)

Smh.P)

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

K130432 510(k)

Page 1 of · 1

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

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