DUET DRF

K103038 · Cmt Medical Technologies, Ltd. · JAA · Mar 29, 2011 · Radiology

Device Facts

• Record ID: K103038
• Device Name: DUET DRF
• Applicant: Cmt Medical Technologies, Ltd.
• Product Code: JAA · Radiology
• Decision Date: Mar 29, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use

Device Story

Duet DRF is a digital image acquisition system utilizing an integrated flat panel digital detector (FPD) for radiography and fluoroscopy. The system captures X-ray signals, digitizes them, and processes images for clinical review. It formats output images according to DICOM protocols for transmission over a network. Operated by healthcare professionals in clinical settings, the device facilitates diagnostic imaging workflows. It does not perform mammography. The system relies on object-oriented software for image processing and connectivity, enabling clinicians to view and manage patient images to support diagnostic decision-making.

Clinical Evidence

Bench testing only. The device was verified and validated in accordance with 21 CFR 820.30 regulations. No clinical data was required or presented.

Technological Characteristics

Digital radiography/fluoroscopy system featuring an integrated flat panel digital detector (FPD). Utilizes object-oriented software for image processing and DICOM-compliant network connectivity. Class II device under 21 CFR 892.1650.

Indications for Use

Indicated for use in radiography or fluoroscopy x-ray examinations to capture, digitize, and review images. Not intended for mammography.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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

• DRF 4343 (K080859)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(m))

Kl.03038

l

, I

## Device Name Proprietary Device Name: Duet DRF

## Establishment Name and Registration Number of Submitter

MAR 2 9 2011

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: Regulation Number: Common Name: Classification Name: Regulatory class:

MOB [phone] Solid state X-Ray imager Image intensified fluoroscopic x-ray system Class II

Reason for 510(k) Submission Abbreviated 510(k) Submission

Identification of Legally Marketed Equivalent Devices K080859 DRF 4343

### Device Description

The Duet DRF is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) same as in K080859 DRF 4343, Villa sistemi medicali S.p.A. (this is the 510(k) for the system that incorporate the same flat panel detector and state of the art object-oriented software and connectivity.

#### Indications for use

The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection.

· This device is not intended for mammography use

#### Safety & Effectiveness

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

#### Substantial Equivalency

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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.

Public Health Service

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

Mr. Shlomi Dines Director of Quality and Regulatory Affairs CMT Medical Technologies, Ltd. Hacarmel St. Bld 7/2, PO Box 111, Industrial Park YOQNEAM ILIT 20692 ISRAEL

AUG 2 0 2013

0 2013

Re: K103038 Trade/Device Name: Duet DRF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MOB Dated: December 14, 2011 Received: February 22, 2011

Dear Mr. Dines:

This letter corrects our substantially equivalent letter of March 29, 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

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

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

{3}------------------------------------------------

## Indications for Use

1103038 510(k) Number (if known):

Duet DRF Device Name:

Indications For Use: The Duet DRF is a digital image acquisition system to be used in conjunction with a solid state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection.

This device is not intended for mammography use

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

AND/OR

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)

Mary S Pastls
(Division Sign-On

Office of In

'510K K103038

Page 1 of