AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS

K081963 · Agfa Healthcare Corporation · MQB · Jul 25, 2008 · Radiology

Device Facts

• Record ID: K081963
• Device Name: AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
• Applicant: Agfa Healthcare Corporation
• Product Code: MQB · Radiology
• Decision Date: Jul 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control. When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients. Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.

Device Story

Computed radiography system; captures x-ray images via photostimulable plates; plates scanned by laser diode array; converts latent images to digital format. NX 2008 workstation software processes images using Musica, Musica2, or Musica2 Platinum algorithms; allows preview, adjustment, storage, printing, or transmission to PACS. Used in clinical settings by healthcare professionals. Provides diagnostic quality images to aid physician diagnosis; supports radiotherapy planning and quality control. System features improved configuration tools and DICOM veterinary data support.

Clinical Evidence

Bench testing only. Components tested to EN 60601-1-1 and EN 60601-1-2 standards. No clinical data provided.

Technological Characteristics

Photostimulable plates; laser diode array scanner; digital image processing; DICOM connectivity. Complies with EN 60601-1-1 and EN 60601-1-2. Software-based image processing (Musica, Musica2, Musica2 Platinum).

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic imaging of the skeleton, chest, abdomen, urological, tomographic, and dental regions. 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

• Agfa's Computed Radiography Systems with NX2.0 Workstations (K071162)

Submission Summary (Full Text)

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K081963

Agfa Corporation Agra Corporation
Premarket Notification: Computed Radiography Systems With NX 2008 Workstations JUL 2 5 2008

# 510(k) Summary DX-Si

Common/Classification Name: Computed Radiography, 21 CFR 892.1650 Proprietary Name: Computed Radiography (CR) Systems with NX 2008 Workstations

Agfa HealthCare Corporation 10 South Academy Street Greenville. SC 29602-9048

Contact: Jeffery A. Jedlicka, Prepared: May 6, 2008 Telephone: [phone] Facsimile: [phone]

### A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's computed Radiography Systems with NX 2008 Workstations. The predicate devices are Agfa's Computed Radiography Systems with NX2.0 Workstations (K071162).

### DEVICE DESCRIPTION B.

The predicate and new devices are nearly identical computed radiography imaging systems. NX 2008 systems (new devices) have updated hardware and software that offers:

- An optional medical grade display. The display is cleared separately . by the display manufacturer.
- The capability to operate as a mixed-use system for both general . radiography and mammography (where approved or licensed). This is not the case for the USA the separately licensed mammography system is not available.
- Improved tools for installation, configuration and management. .
- The ability to receive DICOM veterinary images and data. .

The basic principles of operation of the new and predicate devices are the same. They have the same underlying technological characteristics.

#### INTENDED USE C.

Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.

The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

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When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.

When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients.

Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.

#### SUBSTANTIAL EQUIVALENCE SUMMARY D.

These Computed Radiography (CR) Systems With NX 2008 Workstations have the same indications for use statement as the legally marketed predicate devices (those with NX2.0 software).

The intended uses of the new and predicate devices are highly similar.

- . Users of the new device have the ability to purchase the device with a separately cleared medical grade display instead of reading images only on other (external) medical displays, or on films.
- The system can operate in a mixed-use mode for general radiography . and mammography (not in the USA).
- . The ability to receive and transmit DICOM veterinary images.
- The user interface and system documentation are available in a . number of additional languages.
- Installation, configuration and management of the system is simplified .

Digitizers and cassettes are unchanged from the predicates.

The differences do not alter the intended therapeutic/diagnostic effect.

#### TECHNOLOGICAL CHARACTERISTICS ui

The technological characteristics are the same in the proposed and predicate devices. Both the predicate and new devices use x-rays received by photostimulable plates to create latent diagnostic images. Plates are then scanned by a laser diode array which converts the images into a digital form that can be previewed, adjusted if necessary, then stored locally, sent to an archive, printed or sent to a softcopy capable display such as a PACS system.

### F. TESTING

Agfa's Computed Radiography (CR) Systems with NX2008 Workstations have been tested for proper performance to specifications through various internal tests. Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2. No clinical testing was involved

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## G. CONCLUSIONS

This 510(k) 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

MAY - 7 2012

Re: K081963

Trade/Device Name: Computed Radiography (CR) Systems with NX 2008 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: July 9, 2008 Received: July 10, 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of July 25, 2008.

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. Iisting 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 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 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):

Device Name: Computed Radiography (CR) Systems with NX 2008

Indications for Use:

Agfa's Computed Radiography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis.

The systems can be used with either Musica, Musica2 or Musica2 Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.

When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.

When used with Musica2 Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients.

Agfa's Computed Radiography Systems with NX 2008 software are not indicated for use in mammography.

Prescription Use × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hopal Mwhan

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K081963 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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