(56 days)
Not Found
No
The document describes a software package for viewing and manipulating dental x-ray images, but there is no mention of AI, ML, or any related technologies like deep learning or algorithms that learn from data. The focus is on image display and manipulation features.
No.
The device is described as a software package for viewing and manipulating dental x-ray film images for diagnostic review, insurance adjudication, and patient consultation. It does not provide any direct therapeutic action or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Radiograph viewing and manipulation for diagnostic purposes" and lists several dental diseases/conditions for which the device will be used to diagnose.
Yes
The device is described as a "software package" designed to operate on a "standard PC-compatible computer" for viewing and manipulating dental x-ray images. The description focuses solely on the software's functionalities and does not mention any accompanying hardware components developed or provided as part of the device.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use for Diagnostic Purposes: The intended use explicitly states "Radiograph viewing and manipulation for diagnostic purposes" and lists specific dental diseases and conditions it will be used to diagnose (dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, etc.). This directly aligns with the definition of an IVD, which is used to diagnose diseases or other conditions.
- Analysis of Patient Samples (Indirectly): While the device doesn't directly analyze a biological sample in the traditional sense (like blood or urine), it analyzes a radiograph, which is a representation of the patient's internal anatomy obtained through a medical imaging process. The interpretation of this radiograph is used to make a diagnosis. Regulatory bodies often consider devices that analyze medical images for diagnostic purposes as falling under the IVD umbrella, especially when they are used to identify specific diseases or conditions.
- Predicate Device: The mention of a predicate device (K955237 TAU Corporation TigerScan/TigerView) is a strong indicator that this device is being submitted for regulatory review as a medical device, and given its diagnostic intended use, it's highly probable it's being classified as an IVD.
In summary, the primary intended use for diagnosing specific dental conditions based on the analysis of patient radiographs strongly suggests that this device is an IVD.
N/A
Intended Use / Indications for Use
Intended uses in the dental industry include the following:
- Radiograph viewing and manipulation for insurance claims adjudication. .
- Radiograph viewing and manipulation for diagnostic purposes ●
- Radiograph viewing for patient education and consultation. .
When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.
Product codes (comma separated list FDA assigned to the subject device)
90 EHD
Device Description
The KODAK DIGITAL SCiENCE™ Dental Image Viewer is a software package designed to provide full resolution digitized images of a dental x-ray film for diagnostic review, insurance adjudication and patient consultation. The KODAK DIGITAL SCIENCE™ Dental Image Viewer is designed to operate on a standard PC-compatible computer.
KODAK DIGITAL SCIENCE™ Dental Image Viewer features the display of full-mouth sets and other mounts, high-resolution image display and manipulation, and interfaces with practice management systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dental x-ray film
Anatomical Site
Not Found
Indicated Patient Age Range
general public
Intended User / Care Setting
general practitioners and specialists in the dental care field.
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.
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
NOV 1 1 1) 1697
. )
510(k) SUMMARY OF SAFETY AND EFFECTIVE NESS
I. Date Prepared:
September 12, 1997
ll. Submitter:
Eastman Kodak Company Health Imaging Division Dental Business unit 343 State Street Rochester, New York 14650
III. Contact Person:
Judith A. Wallace Regulatory Affairs (716) 724-2314
IV. Device Name:
Kodak Digital Science Dental Image Viewer Trade Name
Dental x-ray image enhancement system Common Name
V. Device Classification:
FDA has classified the predicate device as Regulatory Class II under CFR 892.1750
VI. Predicate Device:
TAU Corporation TigerScan/TigerView -- 510(k) No. K955237
VII. Description of Device:
The KODAK DIGITAL SCIENCE™ Dental Image Viewer is a software package designed to provide full resolution digitized images of a dental x-ray film for diagnostic review, insurance adjudication and patient consultation. The KODAK DIGITAL SCIENCE™ Dental Image Viewer is designed to operate on a standard PC-compatible computer.
KODAK DIGITAL SCIENCE™ Dental Image Viewer features the display of full-mouth sets and other mounts, high-resolution image display and manipulation, and interfaces with practice management systems.
1
VIII. Indications for Use:
Intended uses in the dental industry include the following:
- Radiograph viewing and manipulation for insurance claims adjudication. .
- Radiograph viewing and manipulation for diagnostic purposes ●
- Radiograph viewing for patient education and consultation. .
When used for diagnostic purposes, the patient population will be the general public, and the diseases/conditions that the device will be used to diagnose are; dental caries, periodontal disease and bone loss, tooth fractures, jaw misalignment, and other diseases and conditions that are encountered by general practitioners and specialists in the dental care field.
IX. Substantial Equivalence:
The purpose and functionality of the KODAK DIGITAL SCIENCE™ Dental Image Viewer is substantially similar to the TAU Corporation TigerView system (K955237), as well as numerous other x-ray viewers currently on the market. The basis for the equivalence is that both systems consist of software which will enhance images for diagnosis. The following table summarizes the two products functional equivalence
| Description | Kodak Dental Image
Viewer | TAU TigerView |
|---------------------------------------|----------------------------------------------|-------------------------------------------------------------|
| Host Platform: | Pentium Processor based
Personal Computer | IBM - Compatible
Computer |
| Operating System: | Windows 95 | Windows 3.1. Windows for
Workgroups 3.11 or
Window 95 |
| Host RAM: | 32 MB | 16 MB |
| Host Magnetic Storage: | 10 MB | at least 400 MB |
| Host Floppy Drives: | 3.5 inches | 3.5 inches |
| Host Processor Speed: | Any Pentium speed | 486 66Mhz or better CPU |
| Host Monitor Size: | 15" diagonal minimum | |
| Display resolution | 800 X 600 at 24 bit color
minimum | 800 X 600 |
| Open Case Preview: | No | Yes |
| User Display Preferences: | Yes | No |
| Receive Images from other
Systems: | Yes | Yes |
2
| Description | Kodak Dental Image
Viewer | TAU TigerView |
|--------------------------------------|---------------------------------------------|----------------------------------------------------------------|
| Patient List Transmission
Status: | No | Receiving status is
displayed. |
| Image Manipulation: | Rotate, Zoom, Flip,
Contrast, Brightness | Rotate, Zoom, Flip,
Contrast, Brightness,
Negative Image |
| Monitor Calibration: | Yes | |
KODAK DIGITAL SCIENCE - Dental Image Viewer 510(k) Submission
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 100 1997
Judith A. Wallace Regulatory Affairs Associate Eastman Kodak Company Health Imaging Division, Dental Business 343 State Street Rochester, NY 14650-1122
Re: K973476
Kodak Digital Science - Dental Image Viewer Dated: September 12, 1997 Received: September 15, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD
Dear Ms. Wallace:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
hJliau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known):
Device Name: KODAK DIGITAL SCIENCE - Dental Image Viewer Indication of use: Viewing of dental radiographic film
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | |
| Over-The-Counter | ____ |
KODAK DIGITAL SCIENCE - Dental Image Viewer
510(k) Submission
| (Division Sign-Off) | |
|---|---|
| 9/12/97 | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K973476 |