X3C DIGITAL RADIOGRAPHIC DETECTOR

K070079 · Imaging Dynamics Company , Ltd. · MQB · Jan 31, 2007 · Radiology

Device Facts

• Record ID: K070079
• Device Name: X3C DIGITAL RADIOGRAPHIC DETECTOR
• Applicant: Imaging Dynamics Company , Ltd.
• Product Code: MQB · Radiology
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The X3C (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of headto-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The X3C (510k submission device) is not intended for mammography.

Device Story

X3C Digital Radiographic Detector is a modified CCD-based imager designed for integration into existing stationary radiography systems. Operated by physicians or technologists in clinical settings, the device captures X-ray exposures to produce diagnostic images of various body parts. The primary modification from the predicate is the replacement of the scintillator. The device functions as a component within a larger radiographic system; it does not perform independent diagnostic analysis. Benefits include providing users an updated imager option for existing systems. Clinical utility is derived from standard radiographic imaging workflows.

Clinical Evidence

No clinical data provided for the X3C specifically. Substantial equivalence is supported by five years of clinical data and field experience involving millions of examinations on human patients for the predicate Xaminer device.

Technological Characteristics

CCD-based digital radiographic imager; stationary X-ray system integration; modified scintillator; power source, controls, and user interface identical to predicate. Complies with USFDA recognized performance standards and ISO, IEC, and EN standards.

Indications for Use

Indicated for diagnostic radiographic imaging of skull, spine, chest, abdomen, and extremities in adult and pediatric patients. 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.

Predicate Devices

• Xaminer (K070079)

Submission Summary (Full Text)

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070079

# Special 510k Submission X3C Digital Radiographic Imager

JAN 3 × 2007

### Summary Statement:

The X3C Digital Radiographic Detector (510k submission device) is substantially equivalent to the Xaminer (predicate device). The CCD imagers in both the X3C Digital Radiographic Detector (510k submission device) and the Xaminer (predicate device) are identical. Traditionally the Xaminer (predicate device) has been fitted into existing radiography systems. The X3C Digital Radiographic Detector (510k submission device) is a modified imager will also be fitted into existing radiography systems.

Information supporting claims of substantial equivalency, as defined under the Federal Food, Drug, and Cosmetic Act respecting safety and effectiveness, is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance will the Agency's final rule: " ... 510(k) Summaries and 510(k) Statements .. ' (21 CFR &807) and can be used as a substantial equivalency summary for anyone requesting it from the Agency.

The X3C Digital Radiographic Delector (510k submission device) is substantially equivalent to the Xaminer (predicate device). The replacement of the submission device is the only significant change between the two imagers. Both submission and predicate devices have technological aspects, methods of operation, power sources, controls, user interfaces, and product configuration - with the exception of the scintillator on the X3C Digital Radiographic Detector (510k submission device)

The X3C Digital Radiographic Delector (510k submission device) and the Xaminer (predicate device) are substantially equivalent. Differences, where they exist involve the sciritiliator, these are not significant and do not raise new questions of safety or effectiveness. The X3C Digital Radiographic Detector (510k submission device) provides users an option to buy a new imager to integrate into their existing radiography systems.

The Xaminer (predicate device) received extensive product testing, using USFDA recognized performance Standards and recognized ISO, IEC, and harmonized EN standards conducted by an accredited independent test laboratory. Five years of clinical data/field experience involving millions of examinations on human patients demonstrates the Xaminer (predicate device) is safe, effective and performs as intended. The replacement of scintillator to the Xaminer (predicate device) to create the X3C Digital Radiographic Detector (510k submission device) represents no new or added hazards.

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Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### 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

Ms. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company, Ltd. Suite 151, 2340 Pegasus Way NE CALGARY ALBERTA T2E 8M5 CANADA

AUG 23 2013

Re: K070079

Trade/Device Name: X3C Digital Radiographic Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 5, 2007 Received: January 9, 2007

Dear Ms. Samarappuli:

This letter corrects our substantially equivalent letter of January 31, 2007.

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 requirences as set forus in the quality of evice as described in your Section 510(k) premarket witianow Joa to ogin finding of substantial equivalence of your device to a legally marketed notheation. The I Dr I imany of fication 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 CFF Parts 801 and 11 you desire specific acrise 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 under the MDA regulation (27 °CF FCT at 005); promo goblem/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 may other other general 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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# Special 510k Submission X3C Digital Radiographic Imager

### Indications for Use

KO 70079 510(k) Number (if known):

Device Name: X3C Digital Radiographic Detector

Indications for Use:

The X3C (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of headto-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system.

The X3C (510k submission device) is not intended for mammography.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
|-------------------------------------------------|---|--------|------------------------------------------------|--|
|-------------------------------------------------|---|--------|------------------------------------------------|--|

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

| (Division Sign-Off) | <div style="text-align:left;">David Hyman</div> |
|-------------------------------------------------------------------|-------------------------------------------------|
| Division of Reproductive, Abdominal, and<br>Radiological Devices, | |
| 510(k) Number | K070079 |

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