(267 days)
Not Found
Not found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The description focuses on it being a digital X-ray system used like a film-based system.
No
The device is described as a diagnostic X-Ray system, not one used for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This Device is a digital X-Ray system intended for use in the field of diagnostic X-Ray."
No
The device description explicitly states it is a "digital X-Ray system," which inherently includes hardware components for generating and capturing X-ray images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "digital X-Ray system intended for use in the field of diagnostic X-Ray." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description confirms it's a "digital X-Ray system."
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This X-ray system is a diagnostic imaging device, which is a different category of medical device.
N/A
Intended Use / Indications for Use
This device is called Instant-X and is available as Model 1713 and Model 128. This Device is a digital X-Ray system intended for use in the field of diagnostic X-Ray. The resident physician would use this device just as if it were a film-based system.
Product codes
MOB
Device Description
Not Found
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
resident physician
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. William J. O'Neill President Ann Arbor (A2) Digital Devices (D2) 699 Shynob Court ANN ARBOR MI 48105
AUG 23 2013
Re: K042791
Trade/Device Name: INSTANT-X Models 1713 & 128 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: June 13, 2005 Received: June 15, 2005
Dear Mr. O'Neill:
This letter corrects our substantially equivalent letter of July 1, 2005.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Janine M. Morr Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
ANN ARBOR (A2) DIGITAL DEVICES (D2)
Instant-X 699 Skynob Court Ann Arbor, Michigan 48105 (734) 834-5156 detwjo@aol.com www.jiffyx.com
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850
Dear Sir/Madam:
RE: 510k Number K042791
INDICATIONS FOR USE
This device is called Instant-X and is available as Model 1713 and Model 128.
This Device is a digital X-Ray system intended for use in the field of diagnostic X-Ray. The resident physician would use this device just as if it were a film-based system.
Dated: 12/08/04
Signature: William JONee
Name: William J. O'Neill
Prescription Use
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042791