(88 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The description focuses on standard x-ray technology and image acquisition.
No
The device is an x-ray equipment used for diagnostic imaging, not for treating diseases or conditions.
Yes
Explanation: The device is intended for dental radiographic examinations to produce digital radiographs for dentists and other qualified professionals, which is a diagnostic activity.
No
The device description clearly states it is "extraoral source dental x-ray equipment," indicating it is a hardware device that produces images, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Orthopantomograph® OP30 is an imaging device that uses X-rays to produce images of teeth and oral structures. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "producing digital radiographs," which is an imaging function, not an in vitro diagnostic test.
Therefore, based on the provided information, the Orthopantomograph® OP30 is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
teeth, TM-joints and other oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists and other legally qualified professionals.
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.
CRANEX® Novus (K063459, MUH)
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
510(k) Summary ·
Date:
August 14, 2009
The name of the 510(k) owner:
NOV 2 0 2009
Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160 04300 Tuusula, Finland
Tel: +358 10 270 2000 Fax: +358 9 851 4048
Contact person: Mr. Jouni Onnela, Tel +358 40 747 2550
United States Sales Representative (U.S. Designated agent):
INSTRUMENTARIUM DENTAL INC. 300 West Edgerton Ave. Milwaukee, WI 53207 -6025 Tel: +1 414 747 1030, 800 558 6120 Fax: +1, 414 481 8665
Contact Person: Mr. Frank Kashinski, Tel +1 414 747 6315
Trade name:
Orthopantomograph® OP30
Common name:
Dental panoramic x-ray equipment, digital
Classification name:
System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH)
Predicate device:
CRANEX® Novus (K063459, MUH)
Description:
Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.
Intended use:
The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.
Technological characteristics:
Orthopantomograph® OP30 is otherwise similar to the predicate device but its tube head can produce more power (70-77 kV, 10 mA) than that of the predicate device (70 kV, 7 mA) and it has a smal touch panel instead of membrane buttons for setting of technique factors.
Instrumentarium Dental
| Street address: | Nahkelantie 160, 04300 Tuusula Finland |
|---|---|
| Postal address: | P.O. Box 20, FI-04301 Tuusula, Finland |
| Tel. | +358 45 7882 2000 |
| Fax | +358 45 7882 2506 |
Bank
SWIFT Nordea Bank NDEAFIHH Account: FI9015963000046864
PaloDEx Group Oy, Tuusula, FINLAND
1
Substantial Equivalence:
and the first of the first of the first of the first of the first for the first and y
We consider Orthopantomograph® OP30 is as safe, more effective, and performs as well as or better than the predicate device.
Instrumentarium Dental
Street address: Postal address: Tel. ESX
Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, Fl-04301 Tuusula, Finland
+358 45 7882 2000
+358 45 7882 2506
Bank
SWIFT Nordea Bank NDEAFIHH Account: FI9015963000046864
PaloDEx Group Oy, Tuusula, FINLAND
2
Image /page/2/Picture/0 description: The image shows a logo with three stylized, curved lines stacked on top of each other. The lines are thick and black, and they appear to be descending or flowing downwards. To the left of the lines, there is a partial word in a smaller font size, oriented vertically. The word is cut off, but it appears to be a department name.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jouni Omnela Regulatory Manager Instrumentarium Dental, PaloDEx Group Oy Nahkelantie 160, 04300 Tuusula FINLAND
NOV 2 0 2009
Re: K092591
Trade/Device Name: Orthopantomograph® OP30 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 14, 2009 Received: August 24, 2009
Dear Mr. Omnela:
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); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K092591
Device Name: Orthopantomograph® OP30
Indications for Use:
The Orthopantomograph® OP30 dental panoramic x-ray equipment is intended for dental radiographic examinations by producing digital radiographs of teeth, TM-joints and other oral structures by dentists and other legally qualified professionals.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Peem
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Instrumentarium Dental
Street address: Postal address: Tel. Fax
Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, FI-04301 Tuusula, Finland +358 45 7882 2000 +358 45 7882 2506
Bank
SWIFT Nordea Bank NDEAFIHH Account: Fl9015963000046864
PaloDEx Group Ov Tursula FINI AND