AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS

K071162 · Agfa Healthcare Corp. · MQB · May 8, 2007 · Radiology

Device Facts

• Record ID: K071162
• Device Name: AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
• Applicant: Agfa Healthcare Corp.
• Product Code: MQB · Radiology
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

Agfa's Computed Radiography Systems with NX 2.X Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. The systems are suitable and capable of capturing and displaying two dimensional x-ray images of any anatomy. Accessories are available that extend capability or user convenience when performing certain imaging procedures/anatomies including pediatric, dental, full-length leg or spine, urology, tomography and radiotherapy planning and quality control. Users of systems with NX 2.X software are able, with an optional Musica 2 Platinum software license, to generate improved quality images of the thorax, abdomen and musculoskeletal regions for adult and pediatric patients.

Device Story

Computed radiography system captures x-ray images via photostimulable plates; laser scanning converts latent images to digital format. NX 2.X workstation software provides image preview, adjustment, storage, and transmission to PACS/archives. Features include auto-stitch for large anatomies (spine/leg) and optional Musica2 Platinum image processing for enhanced thorax, abdomen, and musculoskeletal visualization. Used in clinical settings by radiology staff; output aids physician diagnosis. System supports adult and pediatric imaging; excludes mammography.

Clinical Evidence

Bench testing only. Performance verified through in-house imaging tests and compliance with EN 60601-1-1 and EN 60601-1-2 standards.

Technological Characteristics

Photostimulable plates; laser/laser diode array scanning; digital image processing; connectivity to PACS/archives; software-based image enhancement (Musica2 Platinum); compliant with EN 60601-1-1 and EN 60601-1-2.

Indications for Use

Indicated for creating radiographic images of skeleton (skull, spine, extremities), chest, abdomen, and other body parts in adult and pediatric patients. Optional Musica2 Platinum software provides enhanced processing for thorax, abdomen, and musculoskeletal regions. Compatible with accessories for urological, tomographic, dental, and radiotherapy planning/QC. 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 NX1.0 workstations (K053634)

Submission Summary (Full Text)

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K071162

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Premarket Notification: Computed Radiography Systems With NX 2.X Workstations

## 510(k) Summary DX-Si

Common/Classification Name: Computed Radiography, 21 CFR 892.1650 Proprietary Name: Computed Radiography (CR) Systems with NX 2.X Workstations

Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29601

Agfa Corporation

Contact: Jeffery A. Jedlicka, Prepared: April 18, 2007 Telephone: [phone] Facsimile: [phone]

### A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's computed Radiography Systems with NX 2.X Workstations.

The predicate devices are Agfa's Computed Radiography Systems with NX1.0 workstations (K053634).

#### DEVICE DESCRIPTION в.

The predicate and new devices are nearly identical computed radiography imaging systems. NX 2.X systems (new devices) have:

- . An improved image processing package, Musica2 Platinum (optional). provides improved image processing of the thorax, abdomen or musculoskeletal images for adult or pediatric patients.
- . An auto-stitch function that allows users to automatically combine subimages of large patient anatomies (a leg or spine, for example) into a single image.
- The ability to designate one workstation as the central workstation that . has the ability to view exams on all connected workstations.

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 2.X Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. The systems are suitable and capable of capturing and displaying two dimensional x-ray images of any anatomy.

Accessories are available that extend capability or user convenience when performing certain imaging procedures/anatomies including pediatric,

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dental, full-length leg or spine, urology, tomography and radiotherapy planning and quality control.

Users of systems with NX 2.X software are able, with an optional Musica 2 Platinum software license, to generate improved quality images of the thorax, abdomen and musculoskeletal regions for adult and pediatric patients.

#### SUBSTANTIAL EQUIVALENCE SUMMARY D.

These Computed Radiography (CR) Systems with NX 2.X Workstations have the same indications for use as the legally marketed predicate devices (those with NX1.0 software), with the exception that the NX 2.X software will allow users to access enhanced image-processing software called Musica2 Platinum. This capability will be available as an optional software license.

Musica2 Platinum operates with similar algorithms to the predicate systems (K053634). The difference is that Musica2 Platinum operates with algorithm parameters that are adjusted slightly to match images normally encountered in certain clinical applications. This image processing capability will be available as an optional software license. It will provide improved image processing for images of the thorax, abdomen and musculoskeletal regions for adult and pediatric patients.

#### 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 (or 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 NX 2.X Workstations have been tested for proper performance to specifications through various in-house and imaging performance tests. Components have been tested and shown to meet the requirements of EN 60601-1-1 and EN 60601-1-2.

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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/0 description: The image shows the logo for the Department of Health and Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features an eagle with outstretched wings, and the text is written in a clear, sans-serif font.

Public Health Service

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

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

AUG 2 3 2013

Re: K071162

Trade/Device Name: Computed Radiography (CR) Systems with NX 2.X Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 25, 2007 Received: April 26, 2007

Dear Mr. Job:

This letter corrects our substantially equivalent letter of May 8, 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 or any 1 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 pactice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences to be for ar artisting your device as described in your Section 510(k) premarket will anow you to bogin 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 CFF Parts 801 and If you desire specific device 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/ReportalProblem/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 Tod may other other general moneansal 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): K071162

Device Name: Computed Radiography (CR) Systems with NX 2,X

Indications for Use:

Agfa's Computed Radiography Systems with NX 2.X 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 "in luding 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 musculoskelelal regions of adult or pediatric patients.

Agfa's Computed Radiography Systems with NX 2.X software are not indicated for use in mammography.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K071162

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