CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)

K071682 · Alara, Inc. · MQB · Aug 15, 2007 · Radiology

Device Facts

• Record ID: K071682
• Device Name: CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
• Applicant: Alara, Inc.
• Product Code: MQB · Radiology
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The CRystalView T-Series is not indicated for use in mammography.

Device Story

CRystalView T-Series is an electrostatic X-ray imaging system using reusable storage phosphor plates instead of film. System components include phosphor plates, plate carousels, and a scanner/digitizer. Scanner captures X-ray data and transmits it via USB 2.0 to a user-supplied computer. Control software on the external computer processes and displays images for clinical review. Used in clinical settings for general diagnostic radiography. Output allows clinicians to view and interpret anatomical images to support diagnostic decision-making, replacing traditional film/screen systems.

Clinical Evidence

Bench testing only. Alara's laboratory and verification and validation (V&V) testing demonstrated that the device's performance characteristics and diagnostic capabilities are equivalent to the predicate devices.

Technological Characteristics

Electrostatic X-ray imaging system; uses reusable storage phosphor plates. Components: scanner/digitizer, plate carousels, USB 2.0 interface. Class I laser product. Complies with electrical, mechanical, EMC, and laser safety standards.

Indications for Use

Indicated for generating radiographic images of human anatomy for general-purpose diagnostic procedures. Not indicated 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

• Fuji Computed Radiography (FCR) ClearView CS Image Reader (CR-IR363) (K042023)
• DenOptix ALARA Imaging System (K955643)

Submission Summary (Full Text)

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KD71682

PREMARKET NOTIFICATION 510(k) CRystalView® T-Series Computed Radiography System

AUG 1 5 2007

## E. 510(k) Summary Statement

### CRystalView T-Series Computed Radiography System

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

| Submitter: | Alara, Inc.<br>47505 Seabridge Drive<br>Fremont, CA 94538 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 2953719 |
| Contact Person: | Robert Lundberg<br>Director of Regulatory Affairs and Quality Systems<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 18, 2007 |
| Trade Name: | CRystalView® T-Series Computed Radiography System |
| Common Name: | Computed Radiography (CR) System |
| Classification Name: | Solid State X-Ray Imager<br>Class II, 21CFR 892.1650 |
| Product Code: | 90-MQB |
| Predicate Device: | K042023: Fuji Computed Radiography (FCR) ClearView CS<br>Image Reader (CR-IR363)<br>K955643; DenOptix ALARA Imaging System |

#### Product Description:

The CRystal View T-Series System is an electrostatic X-ray imaging system that employs storage phosphor plates in place of conventional X-ray film for radiographic imaging applications. The system provides image data that must then be viewed with an external computer and appropriate software. The CRystal View T-Series System is comprised of the following functional components: Reusable storage phosphor plates, multiple sizes; Plate carousels, corresponding to reusable storage phosphor plate size; The CRystal View T-Series Scanner, an image reader /digitizer. The CRystal View T-Series Scanner / Communications Interface, USB 2.0; Optional Integrated phosphor plate eraser;

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CRystal View T-Series control software and a user or distribution channel-supplied computer system. Image data is sent via a dedicated connection from the CRystalView T-Series Scanner to the computer system, where it is processed and displayed for review.

#### Indications for Use:

The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in generalpurpose diagnostic procedures.

The CRystal View T-Series is not indicated for use in mammography.

#### Rationale for Substantial Equivalence:

The CRystal View T-Series is the equivalent of the DenOptix Imaging System. Its "Intended Use" statement limits the DenOptix Imaging System to dental computed radiography. The Fuji Computed Radiography (FCR) ClearView CS Image Reader uses the same ST-VI Imaging Plates for general computed radiography that is the same "Intended Use" desired for the CRystalView T-Series. Differences between the FCR ClearView and the present device are in the implementation of similar technologies for computed radiography. These differences do not alter the intended diagnostic effect of a computed radiographic imaging system.

#### Safety and Effectiveness Information:

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

Alara's laboratory and V&V testing demonstrate that the CRystal View T-Series performance characteristics and diagnostic capabilities are equivalent to the predicate.

#### Conclusion:

The CRystalView T-Series' performance is substantially equivalent to the DenOptix Imaging System and the FCR ClearView using the ST-VI imaging plates.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The logo is black and white.

# 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

Mr. Robert Lundberg Director, Regulatory Affairs & Quality Systems Alara, Inc. 47505 Seabridge Drive FREMONT CA 94538

AUG 2 3 2013

Re: K071682

Trade/Device Name: CRystalView® T-Series Computed Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 18, 2007 Received: July 20, 2007

Dear Mr. Lundberg:

This letter corrects our substantially equivalent letter of August 15, 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 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 11 you don't 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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PREMARKET NOTIFICATION 510(k) CRystalView® T-Series Computed Radiography System

A|L|A|R|A®
INC.

# C. Indications for Use Statement

| 510(k) Number: | K071682 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | <u>CRystalView^® T-Series Computed Radiography System</u> |
| Indications for Use: | The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. <p>The CRystalView T-Series is not indicated for use in mammography.</p> |

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ーーー Concurrence of CDRH, Office of Device Evaluation (ODE)

D. Whang 8/15/07

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