(23 days)
Gendex Gx-770, Gendex 765DC
No
The description focuses on the hardware components and basic operational parameters of a standard X-ray system, with no mention of AI, ML, or advanced image processing features.
No
The device is described as an X-Ray system intended for diagnostic imaging, not for therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to act as a diagnostic source for radiographic dental imaging."
No
The device description explicitly lists multiple hardware components (X-ray tubehead, Articulation arm, Electronic control unit, etc.) and describes it as an "extraoral source of x-rays," indicating it is a physical hardware device, not software only.
No, 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 Progeny JB-70 Intra Oral X-Ray System is an extraoral source of x-rays used to create radiographic images of the inside of the mouth (intraoral). It does not analyze samples taken from the body.
- Intended Use: The intended use is "to act as a diagnostic source for radiographic dental imaging." This clearly describes an imaging device, not an in vitro test.
The device is an imaging device used for diagnostic purposes, but it operates by generating external radiation to create images, not by analyzing biological samples.
N/A
Intended Use / Indications for Use
The JB-70 Intraoral Dental X-Ray System is to be used as an extraoral source of xrays in Dental radiography.
The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.
Product codes (comma separated list FDA assigned to the subject device)
90 EHD
Device Description
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography.
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System consists of the following main components:
X-ray tubehead
Rotating yoke for tubehead mounting
Articulation arm
Horizontal extension arm
Electronic control unit
Wall mount
8 inch cone
Optional Components:
12 inch cone
8 ft. coil cord with exposure switch
The Power supply is regulated to provide a fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
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): 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.
Gendex Gx-770, Gendex 765DC
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.
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
510(k) Summary FEB 01 2002
as required by CFR section 807.92(c)
I. General Information
| Date: | January 2, 2002 |
|---|---|
| Applicant: | Progeny, Inc. |
| 1807 Barclay Blvd. | |
| Buffalo Grove, Ill. | |
| 60089 | |
| Contact Person: | Alan Krema |
| Telephone: | 847-850-3800 x785 |
- Fax: 847-850-3800
II. Names
Device Name:
1
| Trade Name: | JB-70 |
|---|---|
| Common Name: | Intra Oral X-Ray System |
| Classification Name: | 76 EHD – Unit, X-Ray, Extra oral with Timer |
III. Predicate Devices
Gendex Gx-770 Gendex 765DC
IV. Product Description
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography.
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System consists of the following main components:
page 4-1
1
X-ray tubehead Rotating yoke for tubehead mounting Articulation arm Horizontal extension arm Electronic control unit Wall mount 8 inch cone
Optional Components:
12 inch cone 8 ft. coil cord with exposure switch
The Power supply is regulated to provide a fixed 70 kVp at a fixed tube current of 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.05 to 1.65 seconds.
V. Indications for Use / Rationale for Substantial Equivalence
The JB-70 Intraoral Dental X-Ray System is to be used as an extraoral source of xrays in Dental radiography.
The JB-70 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 Systems on the U.S. market. One is the Dentsply Gx770. The 510(k) number is K935046 . The classification of the Dentsply device is listed as product code 76EHD.
The other currently marketed device is the Gendex 765, manufactured by Dentsply, Inc. the 510(k) number is K992610. The classification of the Gendex 765 is listed as product code 76EHD .
Labeling for the currently marketed devices is included as Appendix B.
2
Comparison Table:
| Characteristic | Gx 770 | Gendex 765 | Progeny JB-70 |
|---|---|---|---|
| Fixed Kv | 70 kVp | 65 kVp | 70 kVp |
| Fixed mA | 7.0 mA | 7.5 mA | 8.0 mA |
| Operator Technique | |||
| Selection | Exposure | ||
| Duration Only | Exposure | ||
| Duration Only | Exposure | ||
| Duration Only | |||
| Suspension | Articulated Arm | Articulated Arm | Articulated Arm |
| X-Ray Field Size | 6.5 cm diameter | 6.0 cm diameter | 6.5 cm diameter |
| Focal Distance | 8 in. cone | ||
| 12 in. cone | 8 in. cone | 8 in. cone | |
| 12 in. cone | |||
| Operator Exposure | |||
| Control | Deadman | ||
| Switch | Deadman | ||
| Switch | Deadman | ||
| Switch | |||
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 JB-70 Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.
3
VII. Conclusion
The Progeny, Inc. JB-70 Intraoral Dental X-Ray System is determined to be substantially equivalent to the predicate devices, the Gendex Gx-770, and the Gendex 765DC. The JB-70 shares the same indications for use, materials, design, operational and functional features to the currently marketed predicate devices listed in section III of this summary. The JB-70 Intraoral Dental X-Ray System is safe and effective when the device is used as labelled.
4
Image /page/4/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Mr. Alan Krema Director of Product Development Progeny, Inc. 1407 Barclay Blvd. BUFFALO GROVE IL 60089
Re: K020070
Trade/Device Name: JB-70 Intraoral X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: January 2, 2002 Received: January 9, 2002
Dear Mr. Krema:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are 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 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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:
| 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" (21 CFR Part 807.97). 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. Snogdon
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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| Page | of |
|---|---|
| - | 1 1 |
510(k) Number (if known): *
Device Name: のお気になる。
Indications For Use:
Statement of Indications for Use:
Intended Use for the Progeny JB-70:
The intended use of the Progeny JB-70 Intra Oral X-Ray System is to act as a diagnostic source for radiographic dental imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Stenson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030010
Prescription Usc (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)