(14 days)
Not Found
No
The summary describes a standard intraoral dental X-ray system with fixed parameters and no mention of AI/ML in the device description, intended use, or specific sections for AI/ML details.
No
The device is described as an X-Ray system intended for "examinations and diagnosis," which are diagnostic uses, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be used for dental radiographic examinations and diagnosis."
No
The device description clearly lists multiple hardware components, including an X-Ray tubehead, articulating arm, wall mount, and electronic control timer. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The de Gotzen "synchro" Intraoral Dental X-Ray System is an imaging device that uses X-rays to create images of the teeth, jaw, and oral structures. It does not perform tests on biological samples.
- Intended Use: The intended use is for "dental radiographic examinations and diagnosis," which is a form of medical imaging, not in vitro testing.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The de Gotzen synchro Intraoral Dental X-Ray System is an Extraoral source of x-rays for Intraoral images in dental radiography.
The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis of the teeth, jaw, and oral structures.
Product codes (comma separated list FDA assigned to the subject device)
90 EHD
Device Description
The de Gotzen synchro Intraoral Dental X-Ray System is comprised of the following main components:
- X-Ray tubehead and yoke .
- . Articulating arm
- Horizontal arm, standard length ●
- Wall Mount
- Electronic control timer (which may be mounted remotely) .
- 8" and 12" Collimating cones .
Optional components:
- . Horizontal arm, short length
- Horizontal arm, long length .
- . Rectangular collimating cone
The power supply (Timer) is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 8ma. Predefined exposure times may be selected directly through the control timer switchpads. The range of exposure time is 0.08 through 3.2 seconds
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K984524, K935046, K000672, K000551, K963699
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY 0-3 2002
2 mm Al | >2.5 mm Al | >2.1 mm Al | >2.0 mm Al |
| | | | | 28 mR/hr at 1m from focal spot | | Less than 2.5 mGy/h |
| Leakage Radiation Compatiabel with Film and Digital | Yes | Yes | Yes | Yes | Yes | Yes |
:
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Conclusion
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The deGotzen synchro Intraoral Dental X-Ray System was found to be /is substantially Equivalent to the predicate devices; the Aztech 70, Gendex Gx770, Siron Heliodent Vario, Dent-x image x-70, and Belmont Belray 096. The de Gotzen synchro shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of an eagle.
Public Health Service
MAY 03 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Gotzen Group, Inc. % Mr. Robert Mosenkis President CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K021245 Trade/Device Name: deGotzen synchro Intraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: April 18, 2002 Received: April 19, 2002
Dear Mr. Mosenkis:
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 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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This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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
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XI. INDICATIONS FOR USE STATEMENT
Applicant: de Gotzen S.r.L.
510(k) Number (if known): k_02/245
Device Name: de Gotzen "synchro" Intraoral Dental X-Ray System
Indications for Use: The de Gotzen "synchro" Intraoral Dental X-Ray System is an Extraoral Source X-Ray System, intended to be used for dental radiographic examinations and diagnosis 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)
| Prescription Use | ✓ | OR | Over-The-Counter Use | _____ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K021245 |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT |
| And Radiological Devices |
510K Number___________________________________________________________________________________________________________________________________________________________________