(33 days)
Not Found
No
The description focuses on the core function of reading and displaying images from phosphor plates, with no mention of AI/ML terms, image processing beyond basic display, or performance metrics typically associated with AI/ML algorithms.
No
The device is used to read and display x-ray images, not to treat a disease or condition.
No
The device is described as a reader for x-ray images, providing display and storage functions. There is no mention of it interpreting or analyzing these images to make a diagnosis or to provide information supporting a diagnosis. It acts as a data acquisition and management system for x-ray images, not a diagnostic tool itself.
No
The device description explicitly states it "reads photostimulable phosphor plates," which implies a physical hardware component is necessary for this function. It is not solely software.
Based on the provided information, the ScanX 14 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ScanX 14 Function: The ScanX 14 reads images from photostimulable phosphor plates that have been exposed to X-rays. It processes and displays these images, which are representations of internal structures of the body, not analyses of biological specimens.
- Intended Use: The intended use describes the device as being used to display and store X-ray images for physicians and medical personnel. This aligns with diagnostic imaging, not in vitro diagnostics.
Therefore, the ScanX 14 is a medical imaging device, specifically a digital radiography reader, and not an IVD.
N/A
Intended Use / Indications for Use
The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose.
Product codes
MQB
Device Description
The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory.
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
physicians and authorized medical auxiliary personnel
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
§ 892.1680 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 U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a person with outstretched arms, composed of three curved lines. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
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. Joseph Carey Director of Quality Assurance Air Techniques, Inc. Corporate Headquarters 70 Cantiague Rock Rd., P.O. Box 870 HICKSVILLE NY 11801
Re: K042397
Trade/Device Name: ScanX 14 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 31, 2004 Received: September 7, 2004
AUG 23 2013
Dear Mr. Carey:
This letter corrects our substantially equivalent letter of October 5, 2004.
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 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 mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality of evice as described in your Section 510(k) premarket wifi anow you to begall maniel equivalence of your device to a legally marketed nothreation. The I Dr Finanig of section 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 If you desire specific ad roo for your are in Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Thouse 1100. For 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (27 Of RT & February Portal Problem/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 Tou inay ovant outer general mornational 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
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Page _1_of 1
STATEMENT OF INDICATIONS FOR USE:
510K Number (if known): K 0 4 2 3 9 7
Device Name: _________________________________________________________________________________________________________________________________________________________________
The ScanX 14 is a device that reads photostimulable phosphor plates that have been exposed in the place of x-ray film and allow those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by physicians and authorized medical auxiliary personnel for this purpose.
This is the same intended use as previously cleared for the ScanX 12 (Formerly ScanX 10), 510(k) number K031198.
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
or
Over the counter use
David G. Ingram
Division Sion-Off Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
510K ScanX 14, August 31, 2004