(41 days)
Not Found
No
The summary describes a standard digital panoramic x-ray system with no mention of AI or ML in the intended use, device description, or performance studies. The lack of information on training/test sets and key metrics further supports this conclusion.
No
The device is an imaging system used for diagnosis, not for treating a disease or condition.
No
Explanation: The device is indicated for producing digital radiographs, which is an imaging function, not a diagnostic one. Diagnostic devices interpret images or data to identify conditions.
No
The device description explicitly states it is a "panoramic extraoral source dental x-ray system" and mentions hardware components like a "digital image receptor (CCD)" and "technique factor settings," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Cranex Novus dental panoramic equipment 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 for diagnosis, monitoring, or screening.
- Cranex Novus Function: The Cranex Novus is an imaging device that produces digital radiographs (X-rays) of anatomical structures (dentition, TM-joints, etc.) within the body. It does not analyze samples taken from the body.
Therefore, the Cranex Novus falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cranex Novus dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Product codes
MUH
Device Description
Cranex Novus is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. Cranex Novus utilizes digital image receptor(CCD). The technique factor settings for panoramic examinations are: 60 kVp or 70 kVp, 7 mA DC and max. 9 s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dentition, TM-joints 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 Cranex Novus corresponds with the intended use.
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
Image /page/0/Picture/1 description: The image shows the word "SOREDEX" in a bold, sans-serif font. To the left of the word is a black, geometric shape that resembles a stylized checkmark or arrow. The text and shape are both black, and the background is white. The overall impression is of a logo or brand name.
510(k) Summary
Date December 14, 2006 DEC 26 2006
Submitters Information
Soredex Palodex Group Oy Nahkelantie 160 FIN-04300 Tuusula Finland Phone: +358 45 78822000 Fax .: +358 9 7015261 Contact: Kai Lanér
Trade Name
Cranex Novus
Common Name
Dental panoramic x-ray equipment, digital
Classification
System, X-ray, Extraoral Source, Digital / MUH
Predicate Device
We consider that Cranex Novus is substantially equivalent in design, composition and function with Cranex D (K043307)
Product Description
Cranex Novus is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. Cranex Novus utilizes digital image receptor(CCD). The technique factor settings for panoramic examinations are: 60 kVp or 70 kVp, 7 mA DC and max. 9 s.
Intended Use
The Cranex Novus dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
Performance data
Verification and validation testing was successfully performed to confirm that Cranex Novus corresponds with the intended use.
1
Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other. The figures are facing to the right.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Kai Lanér Official Correspondent Soredex Palodex Group Oy Nahkelantie 160 FIN 00430 Tuusula FINLAND
DEC 26 2006
Re: K063459
Trade/Device Name: CRANEX NOVUS Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: November 10, 2006 Received: November 15, 2006
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 (Premarket Approval), 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.
Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, and the letters "PA" in a large, bold font in the center. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.
Protecting and Promoting Public Health
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr. Hes made a and regulations administered by other Federal agencies. You must or any I carated and the reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607), lacemig (21 OFF regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality bystelle (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins leter with and w you're ough finding of substantial equivalence of your device to a legally premaince notificated 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 rr you desire specific at Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
Indications for Use
510(k) Number (if known): K063459
CRANEX NOVUS Device Name:
Indications For Use:
The Cranex Novus dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Divenon in i sammincine, Abd . . . . . . . . . 51 Ak, Number
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