INSTANT-X, MODELS 1713 & 128

K042791 · Ann Arbor Digital Devices · MQB · Jul 1, 2005 · Radiology

Device Facts

• Record ID: K042791
• Device Name: INSTANT-X, MODELS 1713 & 128
• Applicant: Ann Arbor Digital Devices
• Product Code: MQB · Radiology
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

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.

Device Story

Instant-X (Models 1713 & 128) is a digital X-ray system; functions as a direct replacement for traditional film-based diagnostic X-ray systems. Operated by resident physicians in clinical settings; captures X-ray signals for diagnostic imaging. Output consists of digital radiographic images for clinical review and decision-making. Benefits include transition from analog film to digital workflow, facilitating faster image acquisition and review.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to existing film-based diagnostic X-ray systems.

Technological Characteristics

Digital X-ray system; stationary form factor. Operates as a digital replacement for film-based radiography. Technical specifications and material standards not detailed in provided documentation.

Indications for Use

Indicated for use in diagnostic X-ray imaging by resident physicians, functioning as a digital replacement for film-based X-ray systems.

Regulatory Classification

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.

Submission Summary (Full Text)

{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 [phone]. 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 [phone] or [phone] 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 [phone] [e-mail] 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