(469 days)
The X -- VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.
X View device consists of 3 components: the sensor and its cable, data box, and a PC with sensor adapter. The sensors outer body is made of hermitically sealed polymer shell which encapsulates a black and white CCD. The sensor attaches to the processing unit via a 3 m cable. The outer dimensions are approximately 40 x 25 x 5 mm with rounded edges.
The Data box relays the data to the computer for display. The data box is white 4 x 9 inch box with a 5 ft USB cable connection.
The X-View System is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing
The X-View System, along with the aforementioned other systems, consists of a sensor and its cable, a sensor adapter, and a personal computer. The sensor and cable are fully waterproof ( IXP 7 standard ) and may be sterilized by full immersion in a disinfectant solution. The sensor's outer body is made of hermetically sealed polymer shell, which encapsulates a black and white CCD. It has an active sensitive area of 600 mm2, an image matrix of 960,000 pixels and renders a minimum 15 lines / mm and a maximum 18 lines /mm.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is primarily a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about the study from the given input. The document mentions the device renders a minimum 15 lines/mm and a maximum 18 lines/mm, but this is presented as a characteristic, not an acceptance criterion with reported performance from a study.
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APR = 1 2004
510 (K) SUMMARY
SUBMITTER:
Contact Person:
Device Name:
Date:
SOMETECH CORPORATION 6669 Peachtree Industrial Blvd Suite J Norcross, Georgia 30092 phone: 770-825-0100 / fax: 770-849-9733 Mr. Ki Cheol Han March 30, 2004 X-View
Device Description
X View device consists of 3 components: the sensor and its cable, data box, and a PC with sensor adapter. The sensors outer body is made of hermitically sealed polymer shell which encapsulates a black and white CCD. The sensor attaches to the processing unit via a 3 m cable. The outer dimensions are approximately 40 x 25 x 5 mm with rounded edges.
The Data box relays the data to the computer for display. The data box is white 4 x 9 inch box with a 5 ft USB cable connection.
Intended Use
The X-View device is used to provide instant images of human oral tissue and teeth without the use of conventional x-ray film.
This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patients mouth instead of film. The sensor automatically captures the images into a computer for viewing, storage or printing. The computer controls all aspects of image acquisition and image display. These functions would include a full mouth display, 200m functions, contrast controls, image inversion, brightness, and pseudo color renditions.
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The X-View System is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing
Just like Trophy's RVG (K962337) and Regam's Sens-A-Ray (K923067) X-View is similar in its intended use. The X-View System, along with the aforementioned other systems, consists of a sensor and its cable, a sensor adapter, and a personal computer. The sensor and cable are fully waterproof ( IXP 7 standard ) and may be sterilized by full immersion in a disinfectant solution. The sensor's outer body is made of hermetically sealed polymer shell, which encapsulates a black and white CCD. It has an active sensitive area of 600 mm2, an image matrix of 960,000 pixels and renders a minimum 15 lines / mm and a maximum 18 lines /mm. The X-View System, along with Sens-A-Ray and RVG, is able to collect images in real - time enabling the dental practice to put more emphasis on the patient Digital media is faster and easier to store. The computer, along with the resident software controls all aspects of image acquisition and display.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM." arranged around the top half of the circle and "USA" on the right side. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Mr. Ki Cheol Han President Sometech Corporation 6669 Peachtree Industrial Blvd., Suite J NORCROSS GA 30092
Re: K024186
Trade/Device Name: X-View Regulatory Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory class: II Product Code: 90 MUH Dated: January 2, 2004 Received: January 2, 2004
Dear Mr. Han:
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 intestate 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, 30 vg and Cosmetic Act (Act) that do not require approval of a premarket approval application, (PHA), 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, I isto recei 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 deviroe can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, GDA 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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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
Page 2
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Indications for Use
510(k) Number (if known): K024186
Device Name: X - VIEW
Indications for Use: The X -- VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Nancy C Brogdon
§ 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.