(15 days)
Not Found
No
The summary describes a standard dental x-ray unit with no mention of AI/ML features, image processing capabilities, or performance studies related to algorithmic analysis.
No
The device is described as a diagnostic x-ray unit for human teeth, and its intended use is to provide an x-ray source for diagnostic purposes, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the unit works as a "diagnostic purpose x-ray source for human teeth."
No
The device description explicitly lists hardware components such as a control box, wall mounting, adjustable support arm, and x-ray generating tubehead, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- This device's function: The PHOT-X II MODEL 303 is an extraoral source dental radiographic x-ray unit. It generates X-rays that pass through the patient's body (specifically, their teeth, jaw, and oral structures) to create an image on film or an image receptor. This is an in vivo diagnostic process (done within the body).
The description clearly states its purpose is to be an "extraoral source dental radiographic x-ray unit" for "diagnostic purpose x-ray source for human teeth". This aligns with the definition of a radiographic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended use is for traditional raciographing for diagnostic purposes of patients upper and lower arch teeth.
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.
All these x-ray systems are AC-powered devices that produce x-rays and are intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Product codes
EHD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
patients upper and lower arch teeth, teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP - 7 2004
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 : 1-800-223-1192, Fax : 1-800-280-7504 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 | |||
| LOCATION | Power circuit board at the arm | ||
| mounting bracket and the control | |||
| panel cannot be separated. | Power circuit board and control | ||
| panel have serial communication | |||
| circuits, and those can be mounted | |||
| separately. | |||
| D. PRE-HEATING TIME | Can be manually adjusted by the | ||
| dip switches on the printed circuit | |||
| board in the control box. | Micro processor monitors over or | ||
| under shoot of the mA, and adjusts | |||
| the pre-heating time automatically. | |||
| E. HIGH VOLTAGE | |||
| GENERATOR | 75 kHz high frequency inverter | ||
| circuit and Cockcroft circuit. | 80 kHz high frequency inverter | ||
| circuit and Cockcroft circuit. | |||
| F. FILAMENT CIRCUIT | 50 kHz high frequency inverter | ||
| circuit | 25 kHz high frequency inverter | ||
| circuit |
1
(6) —CONTINUED
ELECTRICAL AND RADIATION COMPARISON DATA:
| | SIRONA
HELIODENT DS
(K960819) | PLANMECA
PROSTYLE INTRA
(K970975) | BELMONT
Model 2001CP
(K874238) | BELMONT
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.,
23steps | 0.01-3.2sec.,
23steps | 0.01-2.0sec.,
27steps | 0.01-3.2sec.,
23steps | |
| K. Timer accuracy | ±10% | ±10% | ±10% or ±10msec.,
whichever is greater | ±5msec.
(below 0.1sec. setting)
±10msec.
(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
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%
(60kV,10mA) | 5.4mGy/s±40%(60kV,4mA) | |
| 2-Distal end of long cone | | | 7.8mGy/s±40%(70kV,10mA)
2-
2.2mGy/s±40%(60kV,10mA)
2.9mGy/s±40%(70kV,10mA) | 9.4mGy/s±40%(60kV,7mA)
7.1mGy/s±40%(70kV,4mA)
12.4mGy/s±40%(70kV,7mA)
2-
2.4mGy/s±40%(60kV,4mA)
4.2mGy/s±40%(60kV,7mA)
3.1mGy/s±40%(70kV,4mA)
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
potential and tube current. | ±6.0kV
(tube potential)
±0.7mA
(tube current) | ±2.0kV
(tube potential)
±10%
(tube current) | ±10kV,±5mA
(0.01-0.05sec.)
±5kV,±2mA
(0.06-2.0sec.) | ±10kV,±2mA
(below 0.1sec. setting)
±5kV,±1mA
(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
examination and diagnosis of diseases of the teeth, jaw, and oral structures. | | | | |
.
2
- 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)
3
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.
4
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
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