ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM

K032210 · Alara, Inc. · MQB · Oct 2, 2003 · Radiology

Device Facts

• Record ID: K032210
• Device Name: ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
• Applicant: Alara, Inc.
• Product Code: MQB · Radiology
• Decision Date: Oct 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

CRystalView is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

Device Story

Desktop Computed Radiography (CR) system; generates digital x-ray images from photo-stimulable storage phosphor imaging plates exposed via standard X-ray equipment. System components: CR reader, QC workstation with software, cassettes, and imaging plates. Reader scans plates; sends digital data to QC workstation for processing and image enhancement. Output: DICOM 3.0 images and patient data transmitted to PACS. Used in clinical settings by healthcare providers to review diagnostic images. Replaces traditional film/screen radiography; facilitates digital storage and review; improves workflow efficiency.

Clinical Evidence

Clinical concurrence study performed comparing image quality ratings of CRystalView against Agfa ADC Compact. Radiologist assessment found no statistically significant difference in image quality ratings between the two systems.

Technological Characteristics

Desktop CR system; utilizes photo-stimulable storage phosphor imaging plates; Class I laser product; complies with electrical, mechanical, and EMC safety standards. Connectivity via DICOM 3.0 protocol for PACS integration.

Indications for Use

Indicated for generating radiographic images of human anatomy for all general-purpose diagnostic procedures, intended to replace radiographic film/screen systems.

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

• PhorMax Eagle Scanner (K001499)
• Agfa ADC Compact (K974597)

Submission Summary (Full Text)

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032210

Premarket Notification, 510(k) for the CRystalView CR System

Image /page/0/Picture/2 description: The image shows the logo for ALARA Incorporated. The logo consists of the word "ALARA" in large, bold, sans-serif font, with vertical lines separating each letter. Below the word "ALARA" is the word "INCORPORATED" in a smaller, sans-serif font. There is a thick black line above the word "ALARA".

#### 510(k) Summary F.

# CrystalView™ Computed Radiography System

OCT = 2 2003

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

| Submitter: | Alara, Inc.<br>2545 Barrington Court<br>Hayward, CA 94545 | | |
|----------------------|------------------------------------------------------------------------------------|----------|--------------------|
| Contact Person: | Diane M. King<br>VP Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | |
| Date Prepared: | July 18, 2003 | | |
| Trade Name: | CRystalView Computed Radiography System | | |
| Common Name: | Computed Radiography (CR) System | | |
| Classification Name: | Solid State X-Ray Imager (per 21 CFR 892.1650) | | |
| Predicate Device: | PhorMax Eagle Scanner<br>Agfa ADC Compact | 510(k) # | K001499<br>K974597 |

## Product Description:

The Alara CRystalView™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.

### Indications for Use:

CRystalView is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.

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### Rationale for Substantial Equivalence

CRystalView has the same or similar indications for use as the predicate devices. CRystalView shares the same technological characteristics as the predicate devices. However, the descriptive characteristics are not sufficiently precise to assure substantial equivalence. Therefore, Alara has carried out validation and image quality performance testing, including a clinical concurrence study. The results of this testing demonstrate that CRystalView is substantially equivalent to the predicate devices.

### Safety and Effectiveness Information:

CRystalView is a Class II medical device, and a Class I laser product. CRystalView complies with applicable FDA and international standards pertaining to electrical, mechanical. EMC, and laser safety of medical and/or laser devices.

Alara has performed laboratory and clinical studies to demonstrate CRystalView performance characteristics and equivalent diagnostic capabilities as the predicate. The results of these studies show that CRystal View performance characteristics are comparable with those of the predicate devices. Clinically, no statistically significant difference was found in image quality ratings of CRystalView and the Agfa ADC Compact when images were judged by a radiologist.

### Conclusion:

CRystalView performance tests and clinical studies have demonstrated that CRystalView is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

Ms. Diane M. King VP, Regulatory Affairs Alara, Inc. 2545 Barrington Court HAYWARD CA 64545 Re: K032210

Trade/Device Name: Alara CRystalView™ Computed Radiograph System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified Fluoroscopic x-ray system Regulatory Class: II Product Code: 90 MQB Dated: July 18, 2003 Received: July 21, 2003

Dear Ms. King:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification, 510(k) for the CRystalView CR System

#### Statement of Indications for Use E.

| 510(k) Number (if known): | K032210 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Alara CRystalView ^TM Computed Radiography System |
| Indications for Use: | CRystalView is indicated for use in generating<br>radiographic images of human anatomy. It is intended to<br>replace radiographic film/screen systems in all general-<br>purpose diagnostic procedures. |

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use*

・・

Daniel R. Symons

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

(Optional Format 3-10-98)