(36 days)
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No
The summary describes a standard dental X-ray system and associated patient management software without mentioning any AI or ML capabilities for image analysis, diagnosis, or workflow optimization.
No
The device is an X-ray system used to produce diagnostic images, not to treat or cure a disease or condition.
No
This device is described as an X-ray system intended to "produce dental radiographic X-ray images" and "visualize anatomical structures." It acquires and stores images for dentists to review, but it does not intrinsically perform diagnosis or provide diagnostic interpretations.
No
The device description explicitly states it is an "extraoral source dental panoramic and optional cephalometric X-ray system," which is a hardware device. While it includes software components for image management and patient records, the core device is a physical X-ray machine.
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.
- Device Function: The described device is an X-ray system that produces images of the dento-maxillo-facial area. It works by using external radiation to create images of internal structures.
- Lack of Sample Analysis: The device does not analyze biological samples taken from the patient. It directly images the patient's anatomy.
Therefore, based on the provided information, the PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.
By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data
Product codes (comma separated list FDA assigned to the subject device)
EHD
Device Description
The TROPHYPAN/TROPHYPAN C System is a panoramic extra-oral dental x-ray system, already marketed in the United States. Orthoimaging and OMS Imaging software consist of patient management software for dental, orthodontic, and oral surgery practices. By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
dento-maxillo-facial area (dentomaxillofacial region)
Indicated Patient Age Range
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Intended User / Care Setting
dentists
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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I KUPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory
510(k) Summary
K040556
1. Company Identification
Eastman Kodak Company Health Imaging Group 343 State Street Rochester, NY 14650 Establishment Registration: 1317267
Practiceworks, Inc., an Eastman Kodak company 1765 The Exchange Atlanta, GA 30339 Establishment Registration: 1226003
2. Contact Person
Donald Ellis Director, Regulatory Affairs and Quality Systems
3. Device Name
TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory
4. Device Classification
Class II Product Code: EHD
5. Intended Use
The PracticeWorks TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.
6. Device Description
The TROPHYPAN/TROPHYPAN C System is a panoramic extra-oral dental x-ray system, already marketed in the United States. Orthoimaging and OMS Imaging software consist of patient management software for dental, orthodontic, and oral surgery practices. By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging/OMS Imaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of
1
hard and softcopy charts, treatment plans, clinical notes, and clinical exam data.
7. Substantial Equivalence
The modifications to the TROPHYPAN/TROPHYPAN C do not affect the materials, intended use, operating principles, or manufacture of the system as previously cleared. The indications for use and labeling have been modified but are substantially equivalent to the original device. The modification to the TrophyPand C consists of the addition of Orthoimaging/OMS Imaging software accessory for image archiving and management.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2004
Mr. Donald Ellis Director, Regulatory Affairs & Quality Systems Eastman Kodak Company 343 State Street ROCHESTER NY 14650
Re: K040556
Trade/Device Name: TrophyPan C with Orthoimaging/OMSimaging Accessory Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD
Dated: March 1, 2004 Received: March 17, 2004
Dear Mr. Ellis:
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.
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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. Brydon
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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Indications for Use
510(k) Number (if known):
The PRACTICEWORKS, TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce dental radiographic X-ray images of the dento-maxillo-facial area and store these images along with relevant patient examination information for use by dentists.
2040586
By using the TROPHYPAN/TROPHYPAN C System with the Orthoimaging System accessory, the dentist can acquire radiographic images of the dentomaxillofacial region, visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program that enables dental offices to keep records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter
Nancy Chogdon
(Division Sign-Off)
Division of Reproducti vé, Abdor and Radiological Devices 510(k) Number