(15 days)
This extraoral source x-ray system is intended for dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Image-x System (Dental x-ray system)" and an "Indication For Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
Therefore, I cannot provide the requested information based on the input document.
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
AUG - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TG Group, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298 Re: K012355 Image-x System (Dental x-ray system) Dated: July 23, 2001 Received: July 25, 2001 Regulatory Class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Mr. Mosenkis:
Dour Interested your Section 5 IV(k) notification of intent to maket the device referenced above and we have devices We have reviewed your Section 510(K) nontications of the accossure) to Legally marketed procies concerners of to devices American device is substantially equivalent (tor the mackness to tuse sation in the viel ing the Americal Device Amendments, or to devices of to device of to device of to device of to marketed in interstate commerce proc to way 26, 1970, and Cosmetic Act (Act, Art (Act Act, You may).
that have been reclassified in accordance with the provisions of the seat that have been reclassified in accordance with the provisions on the Act. The general controls provisions of the Act .
therefore, market the device, subject to the general c therefore, market the device, subject to the general controls of the real the group.
include requirements for annual registration, listing of devices, good manufacturing pra misbranding and adulteration.
If your device is classified (see above) into either class III (Prematet Approval), it may be subject in the Code of Federal Regulations. If your device is classified (see above) into ellier class it (special controls) in the Code of Federal Regulations to such additional controls. Existing major regulation assumes combinate with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialy equivalent concess G Title 21, Parts 800 to 895. A substantialion (QS) for Medical Devices: Creveral regulation (21 CFR Par
Practice requirements, as set forth in the Quality System Regulation ( Practice requirements, as set forth in the Quality System Negation (CDA) will benfy such assumptions. Failure
820) and that, through periodic QS inspections, the Food and Dru 820) and that, through periodic (S inspections, the Programs Program of PA may publish further announcements to comply with the GMP regulation may result in regulation. The matrical in the mannission does not
concerning your device in the Federal Register. Please to your prematet i concerning your device in the Federal Regiser. Frease not your promise of the Act for devices under the Electronic Product arreer any oongations, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in a classification for your device and This letter will allow you to begally marketed predicated in your break promises of the stars of 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 additionally 809.00 for in vitte If you desire specific advice for your device of Compliance (c301) Additionally, for questions on the promotions on the promotion diagnosic devices), please contact the Office of Collipinatic at (301) 1304-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your a entitled, "Misbranding by reference to prehalist in the Division of Street Assistance assistance assistance at its toll-free number (800)
responsibilities under the Act may b responsibilities under the Act may be obtained theme of the excelled of the sparedrh/dsmaddsmamain.html".
638-2041 or (301) 443-6597 or at its internet address "http://www.fd
Sincerely vours.
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 (s)
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· Page 3
JUL 20 2001
July 19, 2001
of Page_
510(k) Number (if known):_K012355
Device Name: The TGgroup Image X System
Indication For Use:
Indication For Use.
This extraoral source x-ray system is intended for dental radiographic examinations and diagnosis of diseases of the teeth, jaw, and oral structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE). (Division Sign-Off) Division of Reproducth dominal,
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K012355
V Prescription Use (Per 21 CFR 801.109).
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.