XPLORER 1000

K992955 · Imaging Dynamics Corp. · MQB · Jun 2, 2000 · Radiology

Device Facts

• Record ID: K992955
• Device Name: XPLORER 1000
• Applicant: Imaging Dynamics Corp.
• Product Code: MQB · Radiology
• Decision Date: Jun 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Xplorer 1000 is a digital x-ray imager intended as a replacement for x-ray film for general human radiography.

Device Story

Xplorer 1000 is an optical-based digital x-ray imager; replaces conventional x-ray film. Input: incident x-ray energy. Operation: fluorescent screen converts x-rays to visible light; mirror deflects light; lens focuses light onto high-resolution CCD camera; camera produces digital image. Trigger mechanism captures image upon x-ray beam activation; no connection to x-ray generator required. Used in clinical settings for general radiography. Output: digital radiographic images. Healthcare providers use images for diagnostic assessment of bone and anatomy. Benefits: provides digital imaging capabilities equivalent to film-based systems.

Clinical Evidence

Clinical study included 20 human subjects undergoing both conventional and Xplorer 1000 radiography across a range of general anatomy. A panel of 3 radiologists evaluated image quality, finding the Xplorer 1000 equivalent to conventional film. Bench testing verified spatial resolution using line pair targets and phantoms, exceeding American College of Radiologists standards.

Technological Characteristics

Optical-based digital x-ray imager. Components: fluorescent screen, mirror, lens, high-resolution CCD sensor. Energy source: incident x-ray energy. Spatial resolution: 127 microns at 100% MTF. Standalone device; no electrical connection to x-ray generator required.

Indications for Use

Indicated for general human radiography imaging. 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

• IMIX DIGITAL THORAX SYSTEM (K974863)
• conventional radiographic film (21 CFR 892.1840)

Submission Summary (Full Text)

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N - 2 200

DRAFT

## CONFIDENTIAL

Page 10

K992955
page 1 of 2

# 2.1 Summary for Public Disclosure

Submitter Robin Winsor Director - Regulatory Affairs # 151, 2340 Pegasus Way NE Calgary, Alberta T2E 8M5 Canada Tel: [phone] Fax: [phone] E-mail: [e-mail]

Date summary was prepared

August 24, 1999

#### Name(s) of the device

| Trade name | Xplorer 1000 Digital X-ray Imager |
|-------------|-----------------------------------|
| Common name | Digital X-ray Imager |

Classification name Solid State X-ray Imager

#### Identification of predicate device(s)

Equivalency is based on the IMIX DIGITAL THORAX SYSTEM (K974863) and conventional radiographic film (21 CFR 892.1840).

#### Description of the device

The Xplorer 1000 is an optical based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of fluorescent screen. The visible light is deflected by a mirror to a high resolution CCD camera that produces a digital image. The device trigger mechanism ensures that image is captured when the x-ray beam is turned on. The device does not require any connection to the x-ray generator.

#### Intended Use

The Xplorer 1000 is a digital x-ray imager intended as a replacement for x-ray film for general human radiography.

June 1, 2000 IMAGING DYNAMICS CORPORATION Xplorer 1000 Digital X-ray Image

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DRAFT

# Comparison of device characteristics to predicate

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K 992955
Page 2 of 2

| Feature | Xplorer 1000 | IMIX | Film / Screen |
|-----------------------------------------------------|---------------------------|---------|---------------|
| 510(k)/Regulation | Pending | K974863 | 892.1840 |
| Intended Use | General Human Radiography | | |
| Fluorescent screen<br>to convert x-rays to<br>light | Yes | Yes | Yes |
| Mirror to separate<br>x-rays from light | Yes | Yes | No |
| Lens to focus light | Yes | Yes | No |
| CCD to capture<br>image | Yes | Yes | No |
| Spatial Resolution<br>(microns) at 100%<br>MTF | 127 | 200 | <100 |

#### Non-clinical testing

The Xplorer 1000 uses a fluorescent screen of the type used in film / screen radiography to convert x-rays to light. This light is then captured by a high resolution CCD sensor.

To verify the spatial resolution and determine its equivalence to film, tests were performed using line pair resolution targets and radiological phantoms. Resolution was found to exceed the standards set by the American College of Radiologists and, qualitatively, imaging of bone detail, particularly trabeculae, was found equivalent by radiologists.

## Clinical testing

In an image quality study, 20 human subjects were x-rayed both conventionally and with the Xplorer 1000. A range of anatomy was covered representative of general radiography. The results were examined by a panel of 3 radiologists and found equivalent to film.

## Conclusion

Imaging Dynamics concludes that the Xplorer 1000 Digital X-ray Imager is equivalent to the Imix Digital Thorax System (K974863) and conventional radiographic film (21 CFR 892.1840) based upon the following criteria:

- the Xplorer 1000 has the same intended use as the predicate devices; and, .
- the Xplorer 1000 has radiographic performance equivalent to the predicate devices.

June 1 . 2000 IMAGING DYNAMICS CORPORA Xplorer 1000 Digital X-ray In

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JUN - 2 2000**

Robin Winsor Director-Regulatory Affairs Imaging Dynamics Corporation 151, 2340 Pegasus Way, NE Calgary, Alberta Canada T2E 8M5

Re:

K992955 Xplorer 1000 Dated: April 21, 2000 Received: April 24, 2000 Regulatory class: II 21 CFR 892.1630/Procode: 90 MQB

Dear Mr. Winsor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the vice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that mansou in kerotato schilder stime of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include manike the annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to ir your dontols. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice r ans oo ood. 7 Costantany of the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of r mo to the mailer 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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#### 2.3 Indications for Use Statement

Ver/ 3 - 4/24/96 Applicant: Imaging Dynamics Corporation 510 (k) Number (if known): K992955 Device Name: Xplorer 1000 Digital X-ray Imager Indications For Use:

Intended for use in general human radiography imaging similar to the optically coupled CCD based device cleared under 510(k) number K974863.

Not to be used for mammography.

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrance of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Per 21 CFR 801.109) (Optional Format 1-2-96)

David H. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

June 1, 2000 IMAGING DYNAMICS CORPORATION Xplorer 1000 Digital X-ray Imager