PRESTODR 4143

K110849 · Cmt Medical Technologies, Ltd. · KPR · Apr 26, 2011 · Radiology

Device Facts

• Record ID: K110849
• Device Name: PRESTODR 4143
• Applicant: Cmt Medical Technologies, Ltd.
• Product Code: KPR · Radiology
• Decision Date: Apr 26, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The PrestoDR 4143 ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Device Story

PrestoDR 4143 is a digital radiography system utilizing an integrated Pixium 4143 flat panel digital detector (FPD). It captures X-ray signals to produce digital radiographic images. The device is intended for use in clinical settings by healthcare professionals as a replacement for conventional screen-film systems. It incorporates object-oriented software for connectivity and image processing. The system facilitates diagnostic imaging of various anatomical regions, aiding clinicians in clinical decision-making by providing high-quality digital radiographs. It is a modification of the previously cleared PrestoDR Portable (K100400), featuring updated hardware and software components to improve cost-effectiveness and performance while maintaining the same principle of operation.

Clinical Evidence

Bench testing only. The device underwent verification and validation testing in accordance with 21 CFR 820.30 regulations to ensure it meets performance specifications. No clinical data was required or provided.

Technological Characteristics

Digital radiography system featuring an integrated Pixium 4143 flat panel digital detector (FPD). Utilizes object-oriented software for image processing and connectivity. Designed for stationary X-ray system applications. Class II device.

Indications for Use

Indicated for general radiographic examinations of the skull, chest, shoulders, spine, abdomen, and extremities in patients requiring conventional screen-film imaging. Contraindicated for fluoroscopy, angiography, and 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.

Predicate Devices

• PrestoDR Portable (K100400)

Submission Summary (Full Text)

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K110849

# 510(k) Summary of Safety and Effectiveness (is accordance to 21 CFR 807.97(0))

APR 2 6 2011

### Device Name

Proprietary Device Name: PrestoDR 4143

## Establishment Name and Registration Number of Submitter

Name: CMT Medical Technologies Ltd. Registration: 8030112 Submission contact: Shlomi Dines Hacarmel St. Bld 7/2, POB. 111, Industrial Park, Yoqneam Ilit 20692, ISRAEL, Tel:[phone] [phone], Fax:[phone],

#### Device Classification

| Product Code: | MQB |
|----------------------|---------------------------------------------|
| Regulation Number: | 892.1650 |
| Common Name: | Solid state X-Ray imager |
| Classification Name: | Image intensified fluoroscopic x-ray system |
| Regulatory class: | Class II |

Reason for 510(k) Submission Special 510(k) Submission

Identification of Legally Marketed Equivalent Devices K100400 PrestoDR 4143

#### Device Description

The PrestoDR 4143 is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) and CMT's proprietary technology, which incorporates state of the art objectoriented software and connectivity. The legally marketed PrestoDR Portable K 100400 has been modified: To integrate the Pixium 4143 flat panel digital detector (FPD), improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions, intended use and principle of operation were not changed.

#### Indications for use

The PrestoDR 4143, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

#### Safety & Effectiveness

The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the PrestoDR 4143 meets the required specifications. No adverse affects have been detected.

## Substantial Equivalency

It is CMT opinion that the PrestoDR 4143 is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Shlomi Dines Director of Quality and Regulatory Affairs CMT Medical Technologies, Ltd. Hacanean St. 7/2, PO Box 111 Industrial Park YORKNEAM ILIT 20692 ISREAL

AUG 2 0 2013

Trade/Device Name: PrestoDR 4143 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray System Regulatory Class: II Product Code: KPR Dated: March 1. 2011 Received: March 28. 2011

Dear Ms. Dines:

Re: K110849

This letter corrects our substantially equivalent letter of April 26, 2011.

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

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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

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# Indications for Use

K110849

Device Name: PrestoDR 4143

510(k) Number (if known):

Indications For Use: The PrestoDR 4143 ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

10K-

Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

| 510K | K110849 |
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