(48 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses solely on image display capabilities without mentioning any advanced processing or analysis features typically associated with AI/ML.
No.
The intended use and device description state that the software acts as a diagnostic imaging display for dental x-ray images and intraoral video cameras, which is for diagnostic purposes, not therapeutic.
Yes
The 'Intended Use / Indications for Use' and 'Device Description' sections explicitly state that the software is "a diagnostic imaging display" for dental x-ray images.
Yes
The summary explicitly describes the device as "Progeny Imaging software" and its function is solely the display of digital images, indicating it is a software-only device. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a diagnostic imaging display of dental x-ray and intra oral video images. This means it's a tool for visualizing images, not for performing tests on biological samples in vitro (outside the body).
- Device Description: The description reinforces the intended use as a diagnostic imaging display.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing chemical or biological tests, or providing diagnostic information based on such tests.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely image display for visual interpretation by a dental professional.
N/A
Intended Use / Indications for Use
The Progeny Imaging Software is to be used as a display of intraoral radiographic images in Dental radiography.
The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Product codes
MUH
Device Description
The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dental x-rays, Intra oral cameras
Anatomical Site
Not Found
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)
Safety and effectiveness is demonstrated by:
Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.
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
510(k) Summary
APR 26 2007
as required by CFR section 807.92(c)
I. General Information
March 1, 2007 Date:
Applicant: Progeny, Inc. 1807 Barclay Blvd. Buffalo Grove, III. 60089
Alan Krema Contact Person:
847-850-3800 x785 Telephone:
847-850-3800 Fax:
II. Names
Device Name:
PROGENY IMAGING SOFTWARE Trade Name: Common Name: Exra Oral X-Ray System Classification Name: 90 MUH Extra oral source x-ray system
III. Predicate Devices
Gendex Vix Win Pro Schick CDR software
IV. Product Description
The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
1
V. Indications for Use / Rationale for Substantial Equivalence
The Progeny Imaging Software is to be used as a display of intraoral radiographic images in Dental radiography.
The Progeny Imaging Software shares the same indications for use, materials, design, operational and functional features and is therefore substantially equivalent to the predicate devices listed in section III of this summary.
There are several major independent manufacturers of Intra Oral diagnostic Radiographic software display systems on the U.S. market. One is the Gendex Vix Win Pro. The 510(k) number is K060178 . The classification of the Dentsply device is listed as product code 90 MUH.
Another currently marketed device is the Schick CDR software, manufactured by Schick, Inc. The 510(k) number is K022953. The classification of the Schick CDR is listed as product code 90 MUH .
| Comparison Table: | |||
|---|---|---|---|
| Characteristic | Vix Win Pro | CDR | Progeny Imaging |
| K060178 | K022953 | ||
| Implementation | Software Only | Software and Sensor | Software Only |
| Computer | PC | PC | PC |
| Operating System | Windows 98, | ||
| 2000, & XP | Windows 98, | ||
| 2000, XP | Windows XP | ||
| Display Resolution | 1024 x 768 true color | ||
| recommended | SVGA | ||
| USB support | Yes | Yes | Yes |
| Ethernet support | No | No | Yes |
| Images Displayed | Dental x-rays, | ||
| Intra oral images | Dental X-rays, | ||
| Intra oral images | Dental x-rays, | ||
| intra oral images |
2
VI. Safety and Effectiveness Information
Safety and effectiveness is demonstrated by:
Performance testing and verification to meet product specifications. Software testing to validate software design and performance. Hazard analysis and risk level assessment. Same indications for use as predicate devices.
All of the above steps and evaluations combine to demonstrate that the Progeny Imaging Intraoral Dental X-Ray Software is safe and effective when the device is used as labelled.
VII. Conclusion
The Progeny, Inc. Progeny Imaging Software is determined to be substantially equivalent to the predicate devices, the Gendex Vix Win Pro, and the Schick CDR software. The Progeny Imaging software shares the same indications for use, materials, design, operational and functional features to the currently marked predicate devices listed in section III of this summary. The Progeny Imaging software is safe and effective when the device is used as labelled.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol consisting of three curved lines that resemble human figures or waves. The text "DEPARTMENT OF HEALTH & HU" is arranged vertically along the left side of the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089
APR 2 6 2007
Re: K070664
Trade/Device Name: Progeny Imaging software Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 28, 2007 Received: March 9, 2007
Dear Mr. Krema:
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.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a stylized "FDA" in bold letters. The word "Centennial" is written in a cursive font below the FDA letters. There are four stars at the bottom of the logo.
Protesting and Promoting Public Health
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Page 2 --
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KM0664
Statement of Indications for Use:
Intended Use for the Progeny Imaging software:
The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Prescription Use
Daniel G. Bergman
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