CR 85-X

K062742 · Agfa Corporation · MQB · Oct 13, 2006 · Radiology

Device Facts

• Record ID: K062742
• Device Name: CR 85-X
• Applicant: Agfa Corporation
• Product Code: MQB · Radiology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CR85-X is used to scan exposed X-ray cassettes, containing an erasable image plate (IP). This device is part of a system, consisting of X-ray cassettes with erasable phosphor image plates, an identification station for the cassettes and a workstation where the resulting digital image information is further processed and routed. It is intended that this device is only operated in a radiological environment by qualified personnel. To provide diagnostic quality images to aid in physician diagnosis. Intended to provide diagnostic quality images for general radiographic and gastro-intestinal imaging applications.

Device Story

Computed radiography digitizer; inputs exposed X-ray cassettes containing photo-stimulable storage phosphor imaging plates; scans plates with laser to release latent image as light; converts light to digital image file; output sent to workstation for preview, adjustment, storage, printing, or PACS transmission; operated by qualified personnel in radiological environments; improves light collection efficiency compared to predicate; aids physician diagnosis through digital image acquisition.

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated through in-house reliability and imaging performance tests, and compliance with EN 60601-1-1 and EN 60601-1-2 standards.

Technological Characteristics

Computed radiography digitizer; utilizes photo-stimulable storage phosphor imaging plates; laser scanning mechanism; improved light collector; connectivity to workstations/PACS; electrical safety/EMC compliance per EN 60601-1-1 and EN 60601-1-2.

Indications for Use

Indicated for general radiographic and gastro-intestinal imaging applications to provide diagnostic quality images to aid in physician diagnosis. For use by qualified personnel in a radiological environment.

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

• ADC Compact Plus (CR 75.0)

Submission Summary (Full Text)

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Kob2742.

Agfa Corporation Premarket Notification: CR85-X Digitizer September 7, 2006

## 510(k) Summary CR85-X

OCT ] 3 2006

Common/Classification Name: Computed Radiography, 21 CFR 892.1650

Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048

Contact: Judith Harbour, Prepared: September 7, 2006

### LEGALLY MARKETED PREDICATE DEVICES A.

This is a Special 510(k) for a device modification. The modified device is Agfa's CR85-X Digitizer.

The predicate device is Agfa's previous version of the same device, namely the ADC Compact Plus, which was cleared by FDA on 19 September 2001. The indications of the CR 85-X are the same as the predicate device, ADC Compact Plus, currently named the CR 75.0.

#### DEVICE DESCRIPTION B.

The predicate and newly modified devices are computed radiograpy imaging systems. Instead of traditional screens and photographic film for producing the diagnostic image, these systems utilize an "imaging plate," a plate coated with photo-stimulable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. After exposure, this imaging plate is inserted into a digitizer that scans it with a laser and releases the latent image in the form of light that is converted into a digital image file. The image can then be previewed on a computer workstation, adjusted if necessary then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.

The CR85-X and the ADC Compact Plus are similar. The CR85-X utilizes an improved light collector to obtain maximum light efficiency. However, the basic principles of operation are unchanged.

#### ். INTENDED USE

The CR85-X is used to scan exposed X-ray cassettes, containing an erasable image plate (IP). This device is part of a system, consisting of X-ray cassettes with erasable phosphor image plates, an identification station for the cassettes and a workstation where the resulting digital image information is further processed and routed. It is intended that this device is only operated in a radiological environment by qualified personnel.

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#### D. SUBSTANTIAL EQUIVALENCE SUMMARY

Agfa's CR85-X has the same indications for use and the same technological characteristics as the predicate device. This premarket notification has described the characteristics of the devices in sufficient defail to assure substantial equivalence. For the few characteristics that may not be precise enough to ensure equivalence, performance data was collected, and this data demonstrates substantial equivalence. In keeping with the format of a Special 510(k) for Device Modification, performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence.

The technological characteristics are the same in the proposed and predicate devices.

#### ii TESTING

The CR85-X has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests. The device also meets the requirements of EN 60601-1-1 and EN 60601-1-2.

#### G. CONCLUSIONS

This Special 510(k) for Device Modification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health

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Public Health Service

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

Ms. Judith Harbour Manager, Regulatory Affairs AGFA Corporation Healthcare 10 South Academy Street GREENVILLE SC 29602-9048

Re: K062742

AUG 2 3 2013

Trade/Device Name: CR 85-X Digitizer Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 7, 2006 Received: September 14, 2006

Dear Ms. Harbour:

This letter corrects our substantially equivalent letter of October 13, 2006.

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 nredicate 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

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# Indications for Use

510(k) Number (if known):

Kobi2742

Device Name: CR 85-X Digitizer

Indications For Use:

To provide diagnostic quality images to aid in physician diagnosis. Intended to TO provide diagnostic quality intagoe to and gastro-intestinal imaging applications.

**Prescription Use**
(Part 21 CFR 801 Subpart D)

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Over-The-Counter Use (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)

David H. Bergman

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