(7 days)
Not Found
No
The description focuses solely on the mechanical process of developing radiographic film and makes no mention of AI, ML, or image processing.
No
The device is described as a diagnostic device used to process X-ray film, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used..."
No
The device description clearly states it is an "automatic radiographic film processor," which is a hardware device used to develop, fix, wash, and dry film.
Based on the provided information, the DXSS Automatic X-ray Film Processor is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that it is a "diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes." This clearly indicates its role in the diagnostic process.
- Function: The function of processing radiographic film is a crucial step in obtaining a diagnostic image from an X-ray exposure. While the device itself doesn't directly analyze the patient's sample, it processes the medium (the film) that contains the diagnostic information derived from the patient.
- Predicate Device: The mention of a predicate device (K945682 Gendex Processor) which is also a radiographic film processor, further supports its classification as a medical device, and specifically one involved in the diagnostic workflow.
While the device doesn't directly interact with a biological sample in the traditional sense of an IVD (like blood or urine), its role in processing the diagnostic output (the exposed film) from a medical procedure places it within the scope of devices used for diagnostic purposes. The definition of an IVD can encompass devices used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the exposed film containing information about the patient's internal structures.
N/A
Intended Use / Indications for Use
The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
Product codes
90 EGY
Device Description
Dental automatic radiographic film processor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
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
§ 892.1900 Automatic radiographic film processor.
(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
SEP 3 1999
Section E – 510(k) Summary
| Submitted by: | Jim Jacobson
Dental X-ray Support Systems
2124 196th Street SW, Suite B
Lynnwood, WA 98036
Phone: 888-230-9500
Fax: 425-640-2176 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Submitted: | 08/06/99 |
| Trade Name: | DXSS Automatic X-ray Film Processor |
| Common Name: | Film Processor |
| Classification Name: | Dental Automatic Radiographic Film Processor
(Per 21 CFR section 892.1900) |
| Substantial Equivalence: | Gendex Processor K945682 02/09/95 |
| Description of Device: | Dental automatic radiographic film processor |
| Intended Use: | The DXSS Automatic X-ray Film Processor is an
automatic radiographic film processor, a diagnostic
device intended to be used to develop, fix, wash, and dry
automatically and continuously film exposed for medical
purposes. This is the sole purpose of this device. |
| Comparison Summary: | Unlike predicate devices which use rollers and gears to
pull film through a series of open solution tanks, our
processor holds film stationary in one processing tank.
Furthermore, solutions are contained in 4 sealed
reservoirs. Air pressure and vacuum forces the solutions
up to the film, through a valve system. Film is never
touched by a moving part, which is unlike other
processors on the market. Developer temperature and time
is controlled and adjusted automatically by a computer
board. Maintenance is relatively low due to electronic
draining; other processors require frequent manual
cleaning and draining. Chemistry life is prolonged due to
the sealed reservoirs, which also prevent the odors
associated with open solution tanks. No plumbing is
required as it is in most predicate devices. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999
Mr. Jim Jacobson Owner Dental X-rav Support Systems 2124-19610 Street SW Suite B Lynnwood, WA 98036
Dear Mr. Jacobson:
Re:
K992896 DXSS Automatic X-ray Film Processor Dated: August 24, 1999 Received: August 27, 1999 Requlatory Class: II (two) Product Code: 90 EGY 21 CFR 892,1900
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 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). 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 equivalent determination 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 requlatory 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 the Electronic Product 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 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Page | of |
|---|---|
| ------ | ---- |
510(k) Number (if known): K992896
Device Name:
Indications For Use:
Device Name: DXSS Automatic X-ray Film Processor
Applicant: Dental X-ray Support Systems, Jim Jacobson
The DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qimil. A. Seymon
on Sign-Off) vision of Reproductive, Abdominal, E and Radiological D
510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)