← Product Code [MQB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB) · K042397 # SCANX 14 (K042397) _Air Techniques, Inc. · MQB · Oct 5, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K042397 ## Device Facts - **Applicant:** Air Techniques, Inc. - **Product Code:** [MQB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB.md) - **Decision Date:** Oct 5, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended 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. ## Device Story ScanX 14 is a digital radiography system designed to replace traditional x-ray film. It utilizes photostimulable phosphor (PSP) plates as the image receptor. After x-ray exposure, the device reads the latent image stored on the PSP plate; transforms the signal into a digital format; and displays the image on a CRT monitor for clinical review. The system allows for digital storage and later recovery of radiographic images. It is intended for use by physicians and authorized medical auxiliary personnel in clinical settings. By digitizing the radiographic process, the device facilitates efficient image management, storage, and retrieval, supporting diagnostic workflows. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Stationary x-ray system (21 CFR 892.1680). Utilizes photostimulable phosphor (PSP) plate scanning technology. Outputs digital images for display on CRT and computer storage. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - ScanX 12 (formerly ScanX 10) ([K031198](/device/K031198.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K042397](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MQB/K042397) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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