MOBIVISION

K100001 · Almana Medical Imaging · MQB · Jun 25, 2010 · Radiology

Device Facts

• Record ID: K100001
• Device Name: MOBIVISION
• Applicant: Almana Medical Imaging
• Product Code: MQB · Radiology
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone supine position. Not for mammographic use.

Device Story

Mobivision Digital Mobile X-Ray Systems are mobile radiographic units used in clinical settings by trained doctors or technicians. The device captures X-ray images of various body parts (skull, spine, chest, abdomen, extremities) with patients in sitting, standing, or supine positions. The system transforms X-ray radiation into digital diagnostic images. These images are used by healthcare providers to assist in clinical diagnosis. The mobile nature of the system allows for point-of-care imaging, facilitating rapid assessment and potentially improving patient management by reducing the need for patient transport to fixed radiology suites.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mobile digital radiographic system. Operates as a mobile X-ray unit. Components include X-ray generator, tube, and digital detector. Connectivity supports digital image acquisition and transfer. Complies with 21 CFR 892.1720. Sterilization not applicable; standard clinical cleaning protocols apply.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skull, spine, chest, abdomen, and extremities. Patient may be sitting, standing, or supine. Contraindicated for mammography.

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 contains a logo for the Department of Health & Human Services USA. The logo features a stylized human figure with three heads connected by flowing lines, positioned to the left of the text "DEPARTMENT". The text is in bold, sans-serif font. 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

Almana Medical Imaging % Mr. Daniel Kamm, P.E. Regulatory Engineer. Submission Correspondent Kamm & Associates 8870 Ravello Ct. NAPLES FL 34114

AUG 2 3 2013

Re: K100001

Trade/Device Name: Mobivision Digital Mobile X-Ray Systems (various models) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: May 26, 2010 Received: June 3, 2010

Dear Mr. Kamm:

This letter corrects our substantially equivalent letter of June 25, 2010.

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 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

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K100001

Device Name: Mobivision Digital Mobile X-Ray Systems (various models)

Indications for Use:

These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone supine position. Not for mammographic use.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page I of _

Robe K. Becker

of Radiologics

K100001
510K