(150 days)
Not Found
No
The summary describes a standard dental x-ray system with no mention of AI or ML capabilities for image processing, analysis, or any other function.
No.
The device is used for diagnostic imaging (producing radiographs) rather than treating a condition.
Yes
The document states that the device is used for dental radiographic examinations, which is a diagnostic process.
No
The device description clearly states it is an "extraoral source dental x-ray system," which is a hardware device that produces x-rays. It also mentions specific hardware components like the x-ray generator, anode voltages, and anode current.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Minray Function: The Minray dental x-ray system is an imaging device that produces radiographs (images) of internal structures (dentition, jaws, etc.) using X-rays. This is an in vivo process (performed within the living body).
The description clearly states its purpose is to produce images for dental radiographic examinations, not to analyze biological samples.
N/A
Intended Use / Indications for Use
The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.
The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
Minray is an extraoral source dental x-ray system, which produces dental images on intraoral digital or film image receptors. The x-ray generator operates on high frequency and has an DC output. There are two selectable anode voltages 60 kV and 70 kV. Anode current is constant 7 mA. Exposure time can be selected from 20 ms to 3.2 s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dentition, jaws and other 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)
Verification and validation testing was successfully performed to confirm that Minrav corresponds with the intended use.
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.
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
Image /page/0/Picture/0 description: The image shows the word "SOREDEX" in a stylized font. To the left of the word is the date "APR 2 9 2004". The text is black and the background is white. The image appears to be a logo or heading from a document.
510(k) Summary
KO33755
Date November 27, 2003
Submitters Information
Soredex Instrumentarium Corporation Elimaenkatu 22 00510 Helsinki Finland Phone: +358 10 394820 Fax .: +358 9 7015261 Contact: Kai Lanér
Trade Name Minray
Common Name Dental X-ray System
Classification
Unit, X-ray, Extraoral with Timer / EHD
Predicate Device
We consider that Minray is substantially equivalent in design, composition and function with Heliodent DS (K960819).
Product Description
Minray is an extraoral source dental x-ray system, which produces dental images on intraoral digital or film image receptors. The x-ray generator operates on high frequency and has an DC output. There are two selectable anode voltages 60 kV and 70 kV. Anode current is constant 7 mA. Exposure time can be selected from 20 ms to 3.2 s.
Intended Use
The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.
Performance data
Verification and validation testing was successfully performed to confirm that Minrav corresponds with the intended use.
1
Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Mr. Kai Lanér Soredex Instrumentarium Corporation Elimäenkatu 22 B, Helsinki P.O. Box 250 00031 Sordex FINLAND
Re: K033755 Trade/Device Name: Minray Dental X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II
Product Code: 90 EHD Dated: March 10, 2004 Received: March 12, 2004
Dear Mr. Lanér
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,
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
3
K033755 510 (k) NUMBER :
MINRAY DEVICE NAME :
INDICATIONS FOR USE :
:
.
The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.
Prescription Use
(Per 21 CFR 801.109)
Daniel A. Lynn
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .