AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS

K090672 · Agfa Healthcare N.V. · MQB · May 18, 2009 · Radiology

Device Facts

• Record ID: K090672
• Device Name: AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
• Applicant: Agfa Healthcare N.V.
• Product Code: MQB · Radiology
• Decision Date: May 18, 2009
• 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 Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with either Musica or Musica2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. System options and accessories are available for: . Pediatric imaging . Full leg/full spine Radiotherapy planning and QC . Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric . patients) Musica2 Neonatal . In the USA, Agfa's Computed Radiography Systems with NX Workstations are not intended for use in mammography.

Device Story

Computed radiography system captures X-ray signals via photostimulable plates; laser diode array scans plates to convert latent images into digital format. NX workstations provide image processing (Musica/Musica2/Musica2 Platinum), previewing, adjustment, and storage/archiving capabilities. Used in clinical settings by healthcare professionals to aid diagnostic decision-making. Features include dedicated ICU workflow, export/import tools, and remote image presentation via Office Viewer application. System benefits include improved image processing for pediatric skeletal and neonatal applications, facilitating clinical diagnosis through high-quality radiographic visualization.

Clinical Evidence

Bench testing only. Performance verified through internal testing to ensure compliance with EN 60601-1-1 and EN 60601-1-2 requirements.

Technological Characteristics

X-ray imaging system using photostimulable plates and laser diode array scanning. Software includes Musica/Musica2 image processing algorithms. Connectivity via PACS/network. Complies with EN 60601-1-1 and EN 60601-1-2 standards.

Indications for Use

Indicated for providing diagnostic quality radiographic images of the skeleton (skull, spine, extremities), chest, abdomen, and other body parts in adult and pediatric patients. Includes options for full leg/full spine, radiotherapy planning, and neonatal imaging. Contraindicated 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 NX2008 Workstations (K081963)

Submission Summary (Full Text)

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K090672
Page 1 of 2

MAY 18 2009

# 510(K) SUMMARY AGFA COMPUTED RADIOGRAPHY (CR) SYSTEMS WITH NX WORKSTATIONS

Common/Classification Name: Computed Radiography, 21 CFR 892.1650

Proprietary Name: Computed Radiography (CR) Systems with Workstations

Agfa HealthCare N.V.

Septestraat 27

B-2640 Mortsel

Belgium

Contact: Jeffery A. Jedlicka, Prepared: February 20, 2009

Telephone: [phone]

Facsimile: [phone]

#### LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for Agfa's Computed Radiography Systems with NX Workstations. The predicate devices are Agfa's Computed Radiography Systems with NX2008 Workstations (K081963).

#### DEVICE DESCRIPTION B.

The predicate and new devices are nearly identical computed radiography imaging systems. New NX workstations provide the following benefits:

- The capability of presenting images on other computers configured with the Office � Viewer application.
- Musica2 image processing for Neonatal images. ●
- . Improved Musica2 Platinum image processing for pediatric skeletal images.
- An Export/import tool to support future upgrades. .
- A dedicated Intensive Care Unit (ICU) work-flow. ●

The 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 Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis.

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

System options and accessories are available for:

- . Pediatric imaging
- D Full leg/full spine
- Radiotherapy planning and QC .

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K090672
Page 2 of 2

- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric . patients)
- Musica2 Neonatal .

In the USA, Agfa's Computed Radiography Systems with NX Workstations are not intended for use in mammography.

# D. SUBSTANTIAL EQUIVALENCE SUMMARY

Agfa's Computed Radiography (CR) Systems with NX Workstations have the same indications for use statement as the legally marketed predicate devices (those with NX2008 software).

The intended uses of the new and predicate devices are highly similar. NX workstations provide the following new benefits:

- Musica2 image processing for neonatal images. ●
- Improved Musica2 image processing for pediatric skeletal images. .
- NX offer an Export/import tool for previously generated images .
- . NX will support dedicated ICU-flow (Intensive Care Unit).
- NX workstation will be capable of presenting images on other computer configurations, . which are configured with the Office Viewer application.

Digitizers and cassettes are unchanged from the predicates.

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

## 5. TECHNOLOGICAL CHARACTERISTICS

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 NX 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.

#### CONCLUSIONS G.

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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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: K090672

Trade/Device Name: Computed Radiography (CR) Systems with NX Workstations Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 5. 2009 Received: May 6. 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of May 18, 2009.

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 for use stated in the encreated 776, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, DNA 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 rou may, mercrore, manes 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, additional controls: DAStang major 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 that I Dr has intace a cod regulations administered by other Federal agencies. You must or any I cutar statutes and regulaments, 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 11 you don't opening an 1100 cor you 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 Tod thay 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): KC90672

# Device Name: Computed Radiography (CR) Systems with NX Workstations

Indications for Use:

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

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

System options and accessories are available for:

- . Pediatric imaging
- . Full leg/full spine
- Radiotherapy planning and QC ●
- Musica2 Platinum (thorax, abdomen or musculoskeletal regions of adult or . pediatric patients)
- Musica2 Neonatal .

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

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)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K090672 |