(256 days)
Not Found
No
The summary describes image processing for acquisition, processing, and display, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on real-time imaging and standard image processing techniques.
No
This device is an X-ray imaging system used to provide real-time images for diagnostic purposes, not for treating a disease or condition.
No
The device provides real-time x-ray images and information on the position of instruments, but it does not claim to diagnose any condition or disease.
No
The device description explicitly states that the RTLX includes an X-ray source, X-ray sensor assembly, power and X-ray control electronics, and mechanical components, indicating it is a hardware system with integrated software.
Based on the provided information, the RTLX is not an In Vitro Diagnostic (IVD) device.
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 provide information about a person's health.
- RTLX Function: The RTLX is a digital dental X-ray system. It generates X-rays and captures images of internal structures within the mouth. It does not perform tests on biological samples.
- Intended Use: The intended use is to provide real-time X-ray images for dentists during operative treatment, focusing on visualizing anatomical structures and instrument positions. This is a diagnostic imaging function, not an in vitro diagnostic function.
Therefore, the RTLX falls under the category of a medical imaging device, specifically a dental X-ray system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.
Product codes
90 MUH
Device Description
RTLX, for "Real-Time, Low-Intensity X-ray" is the first X-ray imaging system that provides capabilities for instant, full motion, digital radiographs designed specifically for the dental imaging marketplace. RTLX provides capabilities for X-ray generation, radiograph capture, image storage, and image display at up to 24 fps. The full motion, digital radiographs enhance a clinicians ability for "point-and-view" radiographs reducing patient X-ray exposure and time in the chair and improving speed and accuracy for procedure performance. Product appearance and mechanical structure is designed to provide a user friendly system for sensor placement and video control. In addition, printouts can be made of individual video frames.
The RTLX includes an X-ray source and X-ray sensor assembly for generation and acquisition of X-ray signals. Additionally, power and X-ray control electronics are provided, and an image processor is utilized for radiograph acquisition, processing, and display. Mechanical design emphasizes appearance and functionality. Switches, LEDs, and a printer are provided for user input and feedback.
Mentions image processing
Yes
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
dentists
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
510(K) Summary
Date Prepared: June 7, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: (315)453-4545 x224 Fax: (315)453-4550
Device trade name: RTLX Common name: Digital Imaging System Classification Name: Extraoral source x-ray system ( as per 872.1800)
Device Description:
RTLX, for "Real-Time, Low-Intensity X-ray" is the first X-ray imaging system that provides capabilities for instant, full motion, digital radiographs designed specifically for the dental imaging marketplace. RTLX provides capabilities for X-ray generation, radiograph capture, image storage, and image display at up to 24 fps. The full motion, digital radiographs enhance a clinicians ability for "point-and-view" radiographs reducing patient X-ray exposure and time in the chair and improving speed and accuracy for procedure performance. Product appearance and mechanical structure is designed to provide a user friendly system for sensor placement and video control. In addition, printouts can be made of individual video frames.
The RTLX includes an X-ray source and X-ray sensor assembly for generation and acquisition of X-ray signals. Additionally, power and X-ray control electronics are provided, and an image processor is utilized for radiograph acquisition, processing, and display. Mechanical design emphasizes appearance and functionality. Switches, LEDs, and a printer are provided for user input and feedback.
Intended Use:
The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.
Conclusions drawn from comparison:
The RTLX performs the same functions in the same environment as the predicate devices. The RTLX uses the same sensor technology as the Schick Technologies and the Trophy Radioligie systems and has the same real time image functionality and generator specifications as that of the HDLX system. There are some new features offered with the RTLX, but these are built on the same basic functionality offered by the three predicate devices listed and raise no new questions of efficacy or substantial risk.
1
| Feature/System | Panoramic RTLX | Panoramic HDLX | Schick
Technologies CDR | Trophy Radiologie
RVG-S |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | N/A | K943532 | K933455 | K881133 |
| X-ray Energy Source | 70kV/ 100μA | 70kV/ 100μA | N/A (X-ray source
dependent) | N/A (X-ray source
dependent) |
| Image Acquisition speed
( maximum) | 24 frames/second | 30 frames/second | N/A (Still Frames only) | N/A (Still Frames only) |
| Display image resolution | 128x160 @ 24fps -
256x320 @ 6 fps | 768 x 494 | N/Available | N/Available |
| Sensor Sizes | 20.1 x 30.1 mm | 18 mm diameter | 25.2 x 36.5 mm
19.2 x 34.6 mm
14.7 x 20.9 mm | 18.2 x 27.5 |
| X-ray Image Acquisition
Device | CCD Sensor with
Scintillator | Image Intensifier with
CCD Camera | CCD Sensor with
Scintillator | CCD, fiberoptics and
scintillator. |
| Sensor Type | Intraoral Sensor | Intraoral Sensor | Intraoral Sensor | Intraoral Sensor |
| X-ray Source | Extraoral | Extraoral | Extraoral | Extraoral |
| "Window / level"
features | Yes | Yes | Yes | Yes |
| Forward / Reverse / Still
capability | Yes | Yes (Via attached VCR) | Still only | Still only |
| Hard copy Capability | Yes | Yes | Yes | Yes |
| Image Processor/Data
Storage | Personal Computer | Personal Computer | Optional Personal
Computer | Personal Computer |
| Disinfection /
Sterilization | Cold Sterilization and
Disposable sheaths.
Cold sterilization using
3.4% gluteraldehde
Sheath constructed of
low density polyethelene
injected with ethyl /
methyl acrylate by Banta
Healthcare Group | Not Specified | Cold Sterilization and
Disposable sheaths
Sheath constructed of
low density polyethelene
injected with ethyl /
methyl acrylate by Banta
Healthcare Group
(formerly Ling Products
(Applied Technology) | Cold Sterilization and
Disposable sheaths.
Cold sterilization using
3.4% gluteraldehde
Sheath constructed of
low density polyethylene
injected with ethyl /
methyl acrylate by Banta
Healthcare Group
(formerly Ling Products) |
Serjo
.
.
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2000
Ralph J. Flatau Quality Assurance Manager InfiMed, Inc. 121 Metropolitan Drive Liverpool, NY 13088
Re:
K992392 InfiMed RTLX Extraoral Dental System Dated: January 19, 2000 Received: January 21, 2000 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH
Dear Mr. Flatau:
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 legally marketed predicate devices marketed in interstate commerce pror 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). 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 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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regulation may result in regulatory action. In the 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591. 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" (21CFR 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/odrh/dsmamain.html".
Sincerely yours,
David G. Satin, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Indication for Use
510(K) Number ( if known): 99 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
Device Name: RTLX
Indication for Use:
The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation ( DOE)
Prescription Use
Or
Over the counter Use _
Per 21 CFR 801.109
( Optional format 1-2-96)
David A. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number