PHOT-X II, MODEL 303

K042260 · Takara Belmont USA, Inc. · EHD · Sep 7, 2004 · Dental

Device Facts

• Record ID: K042260
• Device Name: PHOT-X II, MODEL 303
• Applicant: Takara Belmont USA, Inc.
• Product Code: EHD · Dental
• Decision Date: Sep 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Intended use is for traditional raciographing for diagnostic purposes of patients upper and lower arch teeth.

Device Story

PHOT-X II Model 303 is an extraoral dental X-ray system consisting of a control box, wall mount, adjustable support arm, and X-ray tubehead. It generates X-rays for diagnostic imaging of human teeth, with output captured on intraoral film or digital receptors. Operated by dental professionals in clinical settings, the device uses an 80 kHz high-frequency inverter circuit to produce X-rays. A microprocessor monitors tube current (mA) to automatically adjust pre-heating time, ensuring consistent radiation output. The control panel and power circuit board are separable via serial communication circuits. By providing controlled X-ray exposure, the device enables clinicians to visualize dental structures, facilitating diagnosis of oral diseases. Benefits include improved diagnostic accuracy through stable X-ray generation and flexible positioning for patient imaging.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by comparative electrical and radiation performance data, including focal point measurement, tube potential, tube current, timer accuracy, and filtration characteristics, demonstrating performance consistent with predicate devices.

Technological Characteristics

Extraoral dental X-ray system. 80 kHz high-frequency inverter circuit with Cockcroft circuit. Features microprocessor-controlled pre-heating system. Focal point 0.7mm x 0.7mm. Rated tube potential 60kV/70kV; tube current 4mA/7mA. Inherent filtration 1.7mm Al equivalent. Connectivity via serial communication between control panel and power circuit board. Wall-mounted form factor.

Indications for Use

Indicated for use as an extraoral source dental radiographic x-ray unit for diagnostic imaging of human teeth, with images recorded on intraoral dental x-ray film or image receptor. For prescription use.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Belmont, MODEL 2001CP (K874238)
• Sirona, HELIODENT DS (K960819)
• Planmeca, PROSTYLE INTRA (K970975)

Submission Summary (Full Text)

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SEP - 7 2004

K042260

#### 510(k) Summary as required by 807.92 10.

- (1) SUBMITTER : Belmont Equipment, A Division of Takara Belmont USA, Inc. Address : 101 Belmont Drive, Somerset, New Jersey 08873 Telephone : [phone], Fax : [phone] Contact person : MR. Masahiro Kanaya Date prepared : August 4, 2004
- (2) DEVICE NAME : PHOT-X II, MODEL 303 Trade Name : PHOT-X II, MODEL 303 Common Name : Dental Periapical X-ray Classification Name : UNIT. X-RAY, EXTRAORAL WITH TIMER (per 21CFR section 872.1800)
- (3) PREDICATE DEVICE : Substantial equivalence is based on following legally marketed devices. Belmont, MODEL 2001CP (K874238) Sirona, HELIODENT DS (K960819) Planmeca, PROSTYLE INTRA (K970975)
- (4) DESCRIPTION OF THE DEVICE : PHOT-X II, MODEL 303 dental x-ray contains; control box, wall mounting, adjustable support arm and x-ray generating tubehead. Package includes Operators Manual, Installation Manual and Warrantee.
- (5) INTENDED USE : Intended use is for traditional raciographing for diagnostic purposes of patients upper and lower arch teeth.
- (6) COMPARISON WITH PREDICATE DEVICES : The following is a comparison of our MODEL 2001CP x-ray, and our new MODEL 303 x-ray.

| | | MODEL 2001CP | MODEL 303 |
|--|------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | A. X-RAY WAVE FORM | DC Constant wave | DC Constant wave |
| | B. FILAMENT | Pre-heating system | Pre-heating system |
| | C. CONTROL PANEL<br>LOCATION | Power circuit board at the arm<br>mounting bracket and the control<br>panel cannot be separated. | Power circuit board and control<br>panel have serial communication<br>circuits, and those can be mounted<br>separately. |
| | D. PRE-HEATING TIME | Can be manually adjusted by the<br>dip switches on the printed circuit<br>board in the control box. | Micro processor monitors over or<br>under shoot of the mA, and adjusts<br>the pre-heating time automatically. |
| | E. HIGH VOLTAGE<br>GENERATOR | 75 kHz high frequency inverter<br>circuit and Cockcroft circuit. | 80 kHz high frequency inverter<br>circuit and Cockcroft circuit. |
| | F. FILAMENT CIRCUIT | 50 kHz high frequency inverter<br>circuit | 25 kHz high frequency inverter<br>circuit |

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## (6) —CONTINUED

### ELECTRICAL AND RADIATION COMPARISON DATA:

| | SIRONA<br>HELIODENT DS<br>(K960819) | PLANMECA<br>PROSTYLE INTRA<br>(K970975) | BELMONT<br>Model 2001CP<br>(K874238) | BELMONT<br>Model 303 | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| A. Focal Point Measurement | 0.7mm×0.7mm | 0.7mm×0.7mm | 0.8mm×0.8mm | 0.7mm×0.7mm | |
| B. Rated tube potential | 60kV | 50,53,55,57,60,63,66,70 kV | 60kV, 70kV | 60kV, 70kV | |
| C. Rated tube current | 7mA | 8mA | 10mA | 4mA, 7mA | |
| D. Maximum rated tube potential | 60kV | 70kV | 70kV | 70kV | |
| E. Rated line voltage | 100VAC-125VAC | 110VAC-115VAC | 120VAC | 120VAC | |
| F. Line voltage range | 90VAC-137.5VAC | 99VAC-126VAC | 105VAC-130VAC | 108VAC-132VAC | |
| G. Range of line voltage regulation | 2.5% | 10% | 2-5% | 2-5% | |
| H. Rated line current | | | 14A at 70KV,10mA | 10.8A at 70KV,7mA | |
| I. Maximum line current | 11A | 9.0A | 17A at 70KV,10mA | 12A at 70KV,7mA | |
| J. Exposure time | 0.01-3.2sec.,<br>23steps | 0.01-3.2sec.,<br>23steps | 0.01-2.0sec.,<br>27steps | 0.01-3.2sec.,<br>23steps | |
| K. Timer accuracy | ±10% | ±10% | ±10% or ±10msec.,<br>whichever is greater | ±5msec.<br>(below 0.1sec. setting)<br>±10msec.<br>(below 0.1sec. setting & up) | |
| L. Inherent filtration | 0.55mmAl Equivalent | 1.0mmAl Equivalent at 70KV | 1.3mmAl Equivalent | 1.7mmAl Equivalent | |
| M. Added filtration | | | 2.0mmAl | 0.3mmAl | |
| N. Minimum filtration permanently<br>in useful beam. | 2.0mmAl Equivalent | 2.0mmAl Equivalent at 70KV | 3.3mmAl Equivalent at 70KV | 2.0mmAl Equivalent at 70kV | |
| O. Nominal roentgen output | 1- | | 1- | 1- | |
| 1-Distal end of regular cone | 10mGy/s±30% | | 6.3mGy/s±40%<br>(60kV,10mA) | 5.4mGy/s±40%(60kV,4mA) | |
| 2-Distal end of long cone | | | 7.8mGy/s±40%(70kV,10mA)<br>2-<br>2.2mGy/s±40%(60kV,10mA)<br>2.9mGy/s±40%(70kV,10mA) | 9.4mGy/s±40%(60kV,7mA)<br>7.1mGy/s±40%(70kV,4mA)<br>12.4mGy/s±40%(70kV,7mA)<br>2-<br>2.4mGy/s±40%(60kV,4mA)<br>4.2mGy/s±40%(60kV,7mA)<br>3.1mGy/s±40%(70kV,4mA)<br>5.5mGy/s±40%(70kV,7mA) | |
| P. Source to skin distance | | | | | |
| 1-Regular cone | 1-203mm | 1-200mm | 1-203mm | 1-203mm | |
| 2-Long cone | 2-305mm | 2-300mm | 2-350mm | 2-305mm | |
| Q. Leaking technique factor | 0.12mA | | 70kV/0.48mA | 70kV/0.14mA | |
| R. Duty cycle | 1:60 | 1:15 | 1:20 | 1:50 | |
| S. Maximum deviation of tube<br>potential and tube current. | ±6.0kV<br>(tube potential)<br>±0.7mA<br>(tube current) | ±2.0kV<br>(tube potential)<br>±10%<br>(tube current) | ±10kV,±5mA<br>(0.01-0.05sec.)<br>±5kV,±2mA<br>(0.06-2.0sec.) | ±10kV,±2mA<br>(below 0.1sec. setting)<br>±5kV,±1mA<br>(0.1sec. setting & up) | |
| T. Intended Use | All these x-ray systems are AC-powered devices that produce x-rays and are intended for dental radiographic<br>examination and diagnosis of diseases of the teeth, jaw, and oral structures. | | | | |

.

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- We plan to start the introduction of this new PHOT-X II, MODEL 303 dental x-ray, as soon as we receive ll. Pre-Market Notification approval from FDA.
If you require any further information, please do not hesitate to contact me at 1-800-223-1192. Ext. 34

Sincerely,

TAKARA BELMONT USA, INC.

Masahiro Kanaya

Vice President

### Enclosures:

- Initial Report of MODEL 303 x-ray Attachment A.
#### Software Information Attachment B.

Our Predicated Device BELMONT MODEL 2001CP BROCHURE (K874238) Attachment C.

Competitors Predicated Device SIRONA HELIODENT DS BROCHURE (K960819) Attachment D.

Attachment E. Competitors Predicated Device PLANMECA PROSTYLE INTRA BROCHURE (K960819)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2004

Takara Belmont USA, Inc. % Ms. Elizabeth Drew Program Reviewer Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K042260

Trade/Device Name: PHOT-X II, Model 303 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: 90 EHD Dated: August 20, 2004 Received: August 23, 2004

Dear Mr. Drew:

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 4. INDICATIONS FOR USE

# Indications for Use

K042260 510(k) Number (if known):

PHOT-X II MODEL 303 Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

PHOT-X II MODEL 303 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor . The design, function and positioning of the x-ray unit is similar to most all other x-ray machines manufactured for this specific purpose over the past thirty years.

Prescription Use
(Part 21 CFR 801 Subpart D)

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)

David R. Segerson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _

510(k) Main - page 6/12