(41 days)
Not Found
No
The description focuses on the hardware, imaging principles (linear tomography), and basic digital imaging capabilities. There is no mention of AI/ML terms or functionalities like image analysis, interpretation, or automated feature detection that would typically involve AI/ML.
No
The device is used for diagnostic imaging (producing X-ray radiographs) and not for treating or rehabilitating a medical condition.
Yes
The device is intended to be used for producing X-ray radiographs of dentition, TM-joints, and other oral structures, including panoramic, TM-joint, and maxillary sinus radiographs. These radiographs are used for examinations, which are diagnostic purposes.
No
The device description clearly details physical hardware components such as X-ray units, film holders, digital sensors, motorized movements, and patient positioning mechanisms. It is a hardware device that produces images, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Orthopantomograph® OP200 and related options are X-ray devices. They produce images of internal structures (dentition, TM-joints, etc.) by passing X-rays through the patient's body. This is an in vivo imaging technique, not an in vitro diagnostic test.
- Intended Use: The intended use clearly states the purpose is to produce X-ray radiographs of anatomical structures, not to analyze biological specimens.
Therefore, this device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Orthopantomograph(R) OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph(R) OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.
Product codes
EHD
Device Description
Panoramic X-ray devices Orthopantomograph(R) OP200, OP200 D and cephalometric options Orthoceph(R) OC200, OC200 D are the next generation in the Orthopantomograph(R) and Orthoceph(R) family. In the case of OP200 and OC200 devices, the image is captured to the film whilst OP200 D and OC200 D offer digital imaging.
The units include patented V-shaped X-ray beam that adapts to the bone density and structure of the human anatomy. In the OP200 D and OC200 D the imaging geometry remains the same as in film-based imaging (OP200, OC200), thereby enabling comparison to earlier film-based studies.
The patient positioning is easy and accurate thanks to motorized movements and three light lines for correct positioning of the patient's head. The patient's midsagittal view can be seen in a panoramic mirror and the electrically locked rigid forehead support is used to stabilize the head. Patient positioning can be performed on the left or right side.
When OP200 or OC200 units are equipped with CR option they have bigger 24x30cm cassette holder in panoramic side. Normal cassette holder size is 15x30cm. With this bigger 24x30cm cassette holder CR imaging plates can be used.
Optional Ortho ID film marking system can be used to store exposure parameters, patient and clinic information to films. Ortho ID is connected to OP200 or OC200 film units.
Equipments are designed to be field upgradeable. This means that for example basic OP200 film unit can be field upgraded to OC200 (cephalometric imaging) or OP200 D digital or OC200 D digital. All different options like OT, CR, etc. can be field upgraded afterwards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
dentition, TM-joints, other oral structures, maxillary sinus
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)
Reference Device(s)
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
FEB - 9 2005
GE Healthcare
December 23, 2004
31
Traditional 510(k) for Orthopantomograph®OP200, OP200D and Orthoceph®OC200, OC200D
Appendix 7: 510(k) Summary
General Electric Company Instrumentarium Corp. Imaging Division Nahkelantie 160, P.O.Box 20 FIN-04301 Tuusula, Finland
T +358 10 394 6500 F +358 10 394 6501
Image /page/0/Picture/9 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized with curved lines, and the circle has decorative elements around its perimeter.
Instrumentarium Corporation, FIN-00031 INSTRUMENTARIUM, Trade Reg. No. 12.570, VAT FI01092226
1
Traditional 510(k) for Orthopantomograph®OP200, OP200D and Orthoceph®OC200, OC200D
510(k) Summary
Manufacturer
Instrumentarium Corp. Imaging division - Now Part of GE Healthcare P.O.Box 20 (Street address: Nahkelantie 160) FIN-04301-Tuusula, Finland
Phone:+358 10 394 6500 Fax: +358 10 394 6501
Contact Person: Kaija Jokela
United States Sales Representative (U.S. Designated agent)
Instrumentarium Imaging Inc. 300 West Edgerton Avenue Milwaukee, Wisconsin 53207 Contact Person: Mark Mason
Phone: 414-747-1030 Fax. 414-481-8665
Product, Classification name
Orthopantomograph® OP200, OP200D, Orthoceph®OC200, OC200D (Dental panoramic x-ray equipment with cephalostat)
Extraoral source X-ray system/ EHD
Requlation number: 872.1800
Substantial Equivalence:
We consider these products are similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976:
| Orthopantomograph®OP100D | #K992385 |
|---|---|
| Orthoceph®OC100D | #K001439 |
| Orthopantomograph® OP100 and | |
| Orthoceph® OC100 | #K973642 |
General Electric Company Instrumentarium Corp. Imaging Division T +358 10 394 6500 Nahkelantie 160, P.O.Box 20 FIN-04301 Tuusula, Finland F +358 10 394 6501
Image /page/1/Picture/19 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.
Instrumentarium Corporation, FIN-00031 INSTRUMENTARIUM, Trade Reg. No.12.570, VAT FI01092226
2
Traditional 510(k) for Orthopantomograph®OP200, OP200D and Orthoceph®OC200, OC200D
The comparsion of characteristics supports substantial equivalence. OP200/OC200/OP200D/OC200D integrates the fetures of the predicate devices to the new platform.
Description:
Panoramic X-ray devices Orthopantomograph® OP200, OP200 D and cephalometric options Orthoceph® OC200, OC200 D are the next generation in the Orthopantomograph® and Orthoceph® family. In the case of OP200 and OC200 devices, the image is captured to the film whilst OP200 D and OC200 D offer digital imaging.
The units include patented V-shaped X-ray beam that adapts to the bone density and structure of the human anatomy. In the OP200 D and OC200 D the imaging geometry remains the same as in film-based imaging (OP200, OC200), thereby enabling comparison to earlier film-based studies.
The patient positioning is easy and accurate thanks to motorized movements and three light lines for correct positioning of the patient's head. The patient's midsagittal view can be seen in a panoramic mirror and the electrically locked rigid forehead support is used to stabilize the head. Patient positioning can be performed on the left or right side.
When OP200 or OC200 units are equipped with CR option they have bigger 24x30cm cassette holder in panoramic side. Normal cassette holder size is 15x30cm. With this bigger 24x30cm cassette holder CR imaging plates can be used.
Optional Ortho ID film marking system can be used to store exposure parameters, patient and clinic information to films. Ortho ID is connected to OP200 or OC200 film units.
Equipments are designed to be field upgradeable. This means that for example basic OP200 film unit can be field upgraded to OC200 (cephalometric imaging) or OP200 D digital or OC200 D digital. All different options like OT, CR, etc. can be field upgraded afterwards.
Intended use:
Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related
General Electric Company Instrumentarium Corp. Imaging Division Nahkelantie 160, P.O.Box 20 FIN-04301 Tuusula, Finland
T +358 10 394 6500 F +358 10 394 6501
Image /page/2/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The circle has a decorative, swirling pattern around its edge. The logo is black and white.
Instrumentarium Corporation, FIN-00031 INSTRUMENTARIUM, Trade Reg. No. 12.570, VAT FI01092226
3
December 23, 2004
34
Traditional 510(k) for Orthopantomograph®OP200, OP200D and Orthoceph®OC200, OC200D
thereto. OP200 or OC200 units can also be equippmed with Ortho Trans (OT) therelo. OF 200 of OC200 units can also be oquipments and longitudinal slices of region of option, which is capable of linear tomography imaging principle.
General Electric Company Instrumentarium Corp. Imaging Division Nahkelantie 160, P.O.Box 20 FIN-04301 Tuusula, Finland
T +358 10 394 6500 F +358 10 394 6501
Image /page/3/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The letters are stylized and connected, and the circle has small, teardrop-shaped elements around its perimeter.
Instrumentarium Corporation, FIN-00031 INSTRUMENTARIUM, Trade Reg. No.12.570, VAT FI01092226
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 2005
GE Healthcare % Mr. Mark Mason US Agent Instrumentarium Imaging, Inc. 300 West Edgerton Avenue MILWAUKEE WI 53207
Re: K043612 Trade/Device Name: Orthopantomograph® OP200, OP2001 Orthoceph® OC200, OC200D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: December 23, 2005 Received: January 13, 2005
Dear Mr. Mason:
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.
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.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lottor with a son. The FDA finding of substantial equivalence of your device to a legally premaince nodicate 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 If you desire specific at neve at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 001:37). I ou may overs, 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
6
GE Healthcare
Traditional 510(k) for Orthopantomograph®OP200, OP200D and Orthoceph®OC200, OC200D
Indications for Use
indications for USe
510(k) Number (if known): ________________________________________________________________________________________________________________________________
Device Name: Orthopantomograph®OP200,OP200D, Orthoceph®OC200, OC200D Indications for Use:
Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.
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)
Nancy C. Thogdon
(Division Sign) Off Division of Reproductive, Abo and Radiological Devices 510(k) Number
General Electric Company Instrumentarium Corp. Imaging Division Nahkelantie 160, P.O.Box 20 FIN-04301 Tuusula, Finland
T +358 10 394 6500 F +358 10 394 6501
Image /page/6/Picture/16 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are white, while the background within the circle is black.
Instrumentarium Corporation, FIN-00031 INSTRUMENTARIUM, Trade Reg. No.12.570, VAT FI01092226