(107 days)
No
The summary describes standard image storage, organization, tracing, analysis, and simulation capabilities, without mentioning AI or ML algorithms. The "growth or surgical predictions" are likely based on traditional cephalometric analysis methods, not AI/ML models.
No
The device is described as software for storing, organizing, tracing, analyzing, and simulating images and measurements for orthodontic and oral surgery practices. It does not directly provide therapy or treatment.
Yes
The device is described as having the "capability to trace a cephalometric x-ray, analyze the measurements taken and make growth or surgical predictions," which indicates it processes images and provides analytical outputs used for clinical decision-making.
Yes
The device is described as "Kodak Orthodontic and OMS Imaging 8.0 software" and is intended for installation on an "off-the-shelf PC running Microsoft Windows". While it interacts with imaging systems, the core device being described and cleared is the software itself, which performs functions like image storage, organization, tracing, analysis, and prediction. The description explicitly states the software "does not natively control any x-ray device".
Based on the provided text, 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 Kodak Orthodontic and OMS Imaging 8.0 software is designed for storing, organizing, analyzing, and planning based on medical images (photographs, x-rays, electronic models). It processes images acquired from the patient's body, but it does not perform tests on biological samples taken from the body.
- Intended Use: The intended use is for clinical staff to manage and analyze images for orthodontic and oral surgery purposes, including tracing cephalometric x-rays and making predictions. This is image-based analysis, not laboratory testing of biological specimens.
The device falls under the category of medical imaging software, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
Kodak Orthodontic and OMS Imaging 8.0 software is intended for use by orthodontists, oral surgeons and their clinical staffs in storing and organizing images, including digital photographs, x-rays, electronic models, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken and make growth or surgical predictions.
Product codes
LLZ, EHD
Device Description
Kodak Orthodontic and OMS Imaging 8.0 software is designed for installation on an off-the-shelf PC running Microsoft Windows in a peer-to-peer network. Identical software is to be supplied to both orthodontic (commercial name: Orthodontic Imaging 8.0) and oral surgery (commercial name: OMS Imaging 8.0) markets. The software consists of patient management software for orthodontic, and oral surgery practices. It provides the ability to connect satellite offices and will be marketed as a base system, with additional modules offered as options. The base system will include the storage, annotation and printing of images. The optional analysis module will allow the user to trace the cephalometric x-rays using standard analyses. The optional planner module will allow the user to simulate orthodontic or surgical treatment. When the system is used with the TrophyPan or TrophyPan C panoramic and cephalometric x-ray systems (K023346, K033690, now marketed as Kodak 8000 and 8000C) the practitioner 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. The software does not natively control any x-ray device, but instead provides the user an interface by which he may access the control panels available with the Kodak 8000/8000C x-ray systems. Kodak Orthodontic and OMS Imaging 8.0 software includes programming that enables the user to retrieve an electronic copy of an x-ray image from other imaging systems. The imaging software can be integrated with Kodak practice management system software or used as a stand-alone product.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays, digital photographs, electronic models
Anatomical Site
dentomaxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthodontists, oral surgeons and their clinical staffs
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
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
Kodak Orthodontic Imaging 8.0 and OMS Imaging 8.0 Software
PracticeWork LLC. A subsidiary of Eastman Kodak Company
FEB 2 4 7005510(k) Summary Kodak Orthodontic and OMS Imaging 8.0 software
1. Company Identification
Practiceworks, LLC, a subsidiary of Eastman Kodak Company 1765 The Exchange Atlanta, GA 30339 Establishment Registration: Pending Owner/Operator Registration: 1315356
2. Contact Person
Dan Hoefer Manager, Regulatory Affairs Kodak Dental Systems
3. Device Name
Kodak Orthodontic Imaging 8.0, Kodak OMS Imaging 8.0 Commercial name: Orthodontic and Oral Surgery Imaging Software Common name: System, Image Processing, Radiological Classification name:
4. Device Classification
II Class: Product Code: LLZ
5. Intended Use
Kodak Orthodontic and OMS Imaging 8.0 software is intended for use by orthodontists, oral surgeons and their clinical staffs in storing and organizing images, including digital photographs, x-rays, electronic models, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken and make growth or surgical predictions.
6. Device Description
Kodak Orthodontic and OMS Imaging 8.0 software is designed for installation on an off-the-shelf PC running Microsoft Windows in a peer-to-peer network. Identical software is to be supplied to both orthodontic (commercial name: Orthodontic Imaging 8.0) and oral surgery (commercial name: OMS Imaging 8.0) markets.
1
The software consists of patient management software for orthodontic, and oral surgery practices. It provides the ability to connect satellite offices and will be marketed as a base system, with additional modules offered as options. The base system will include the storage, annotation and printing of images. The optional analysis module will allow the user to trace the cephalometric x-rays using standard analyses. The optional planner module will allow the user to simulate orthodontic or surgical treatment.
When the system is used with the TrophyPan or TrophyPan C panoramic and cephalometric x-ray systems (K023346, K033690, now marketed as Kodak 8000 and 8000C) the practitioner 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. The software does not natively control any x-ray device, but instead provides the user an interface by which he may access the control panels available with the Kodak 8000/8000C x-ray systems.
Kodak Orthodontic and OMS Imaging 8.0 software includes programming that enables the user to retrieve an electronic copy of an x-ray image from other imaging systems.
The imaging software can be integrated with Kodak practice management system software or used as a stand-alone product.
7. Substantial Equivalence
Kodak Orthodontic and OMS Imaging 8.0 is substantially equivalent to Chairside (K982422, EagleSoft) and DentalEye (K012439, Radco Data AB).
- Each device is indicated for use in dental or dental sub-specialty . diagnostic image storage, editing, communication, manipulation and viewing.
- The technological characteristics and principles of operation are . equivalent, as each device is software that operates on a Windows-based PC platform.
- The intended users of each device are the same or similar. .
- The devices are equivalent in terms of energy used or delivered, materials, . biocompatibility, standards, and other applicable characteristics.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. 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
Re: K043104
FEB 2 4 2005
Trade/Device Name: Kodak Orthodontic Imaging and OMS Imaging Version 8.0 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: January 21, 2005 Received: January 24, 2005
Dear Mr. Hoefer:
Mr. Daniel Hoefer
Kodak Dental System
Practice Works, Inc.
1765 The Exchange
ATLANTA GA 30339
Manager, Regulatory Affairs
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levicwed your becasil b re(x) peopleantially equivalent (for the indications for use stated in above and nave determined the ad predicate devices marketed in interstate commerce prior to the chelosure) to regally maneled production Device Amendments, or to devices that have been May 26, 1770, the chacinent acts of the Federal Food, Drug, and Cosmetic Act (Act) that reciassified in accondation while proval application (PMA). You may, therefore, market the do not require approval of a promance approvisions 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 If your device is classified (600 as 10) alitional controls. Existing major regulations affecting your Apploval), it thay oc subject to Jack aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA uce vice can of round in the eneming your device in the Federal Register.
Please be adviscd that FDA's issuance of a substantial equivalence determination does not mean that FICA 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 I cut at statues and regulations assnot limited to registration and listing (21 CFR Part 807); labeling Act STEQuirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneling of substantial equivalence of your device to a legally premarket nothreation: "The I DA miding of backannal vice 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 advice for your derros on 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 Also, please note the regulation entitled, "formation on your responsibilities under the Act from the 807.77). Tou may obtain other general 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/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
4
Indications for Use
510(k) Number (if known):
Kodak OrthoImaging 8.0 software is indicated for use by orthodontists and their Kodak Orinothiaging 6.0 sortware in minutes rocluding digital photographs and xclinical staff in storing and organizing images, including digital photograph clinical staff in storing and organizatify interests arenally cephalometric radiograph,
rays. The device includes the capability to trace a digital crapications rays. The device mendes the capactive of anywords or surgical predictions.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
Daniel H. Lyman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043104