CR 10-X DIGITIZER

K121948 · Agfa Healthcare N.V. · MQB · Jul 20, 2012 · Radiology

Device Facts

• Record ID: K121948
• Device Name: CR 10-X DIGITIZER
• Applicant: Agfa Healthcare N.V.
• Product Code: MQB · Radiology
• Decision Date: Jul 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used. Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.

Device Story

Computed radiography system captures x-ray images using phosphor-coated imaging plates and cassettes. Laser digitizer scans plates to generate electronic images; NX workstation processes, previews, and routes images for storage or printing. Used in clinical settings for general projection radiography; operated by healthcare professionals. System replaces conventional screen-film systems, providing diagnostic quality images for clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed device meets specifications and operates as planned. Image quality compared to predicate via internal and expert review. Conformance to IEC 60601-1, IEC 60601-1-2, and DICOM standards demonstrated.

Technological Characteristics

Solid-state x-ray imaging system. Components: phosphor-coated imaging plates, laser digitizer, NX workstation. Connectivity: DICOM. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ACR/NEMA PS3.1-3.18 (DICOM), ISO 14971 (risk management), ISO 13485 (quality).

Indications for Use

Indicated for general projection radiographic applications in human anatomy. 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 CR 30-X digitizer (K062223)

Submission Summary (Full Text)

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K121948

JUL 20 2012

Agfa HealthCare NV Premarket Notification: Computed Radiography (CR) Systems with CR 10-X Digitizer

## 510(K) SUMMARY

# Agfa Computed Radiography (CR) Systems with CR 10-X Digitizer

Common Name: Computed Radiography System Classification Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Classification: 21 CFR 892.1650 Product Code: MQB Proprietary Name: Computed Radiography (CR) Systems with CR 10-X Digitizer Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Phil Cuscuna, Prepared: April 10, 2012 Telephone: [phone] Facsimile: [phone]

#### A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's Computed Radiography (CR) System with CR 10-X Digitizer, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's CR 30-X digitizer (K062223).

#### B. DEVICE DESCRIPTION

Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. Principles of operation and technological characteristics of the new and predicate devices are largely the same as other computed radiography systems:

- Phosphor coated imaging plates and cassettes for image capture.
- Laser digitizer for generating the electronic image. .
- NX workstation for image previewing, processing and routing .

### C. INTENDED USE

Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.

Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.

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Agfa HealthCare NV Premarket Notification: Computed Radiography (CR) Systems with CR 10-X Digitizer

### SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa"s Computed Radiography (CR) System with CR 10-X Digitizer has an Indications For Use statement similar to the statement for the predicate device, K062223. Intended uses are the same. The devices have the same technological characteristics. Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

| PRODUCT COMPARISON TABLE | | |
|-------------------------------------|------------------------------------------------|--------------------------------------------------------------|
| | Systems with CR 10-X Digitizer<br>(New Device) | Systems with CR 30-X Digitizer<br>(PREDICATE-K062223) |
| Communications | Same as predicate | DICOM |
| Cassette and Image Plates | | |
| Cassettes and Image<br>Plate Sizes | 35x43 cm | 15x30 cm<br>18x24 cm<br>24x30 cm<br>35x35 cm<br>35x43 cm |
| Image Plate Phosphors | Same as predicate | BaSrFBrI:Eu |
| Digitizer | | |
| Scanning technology | Same as predicate | Point at-a-time |
| Light collection | Same as predicate | Solid, high efficiency |
| Scanning resolution | Same as predicate | 100μ |
| Active matrix | 3420 x 4218 | 3480 x 4248 |
| Dynamic range<br>(acquisition) | Same as predicate | 16 bit, sq. root compressed |
| Throughput<br>(35x43 cm plates/hr.) | 34 | 60 |
| Power Supply | Same as predicate | 100 - 240V 50/60 Hz |
| Mobile installations | Same as predicate | Mobile mounting option |
| Image stitching | Same as predicate | Full Leg Full Spine |
| Workstation | | |
| Image processing | Same as predicate | MUSICA, MUSICA2 |
| Dynamic range<br>(display) | Same as predicate | 12 bit |
| Operating system | Windows 7 | Windows XP Pro |
| Power Supply | Same as predicate | 100 - 240V 50/60 Hz |
| Display System | Same as predicate | Standard PC display or separately cleared<br>medical display |

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#### E. TECHNOLOGICAL CHARACTERISTICS

Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. It uses phosphor coated imaging plates to capture an x-ray exposure. Upon scanning of the image plates by the CR-10-X digitizer, the x-ray image is read and transmitted to the NX workstation where the image can be previewed, processed and transmitted to other devices for viewing, printing or storage.

#### F. TESTING

The device has completed verification and validation testing to confirm it meets specifications and operates as planned. Tests included image quality tests with internal and experts comparing the device to its predicate.

The product, manufacturing and development processes have been shown to conform to product safety, radiology, and imaging standards including:

### PRODUCT STANDARDS

- . IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, plus collateral standard: Electromagnetic compatibility requirements and tests.
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General Requirements For Safety -. Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- . ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM)

### MANAGEMENT STANDARDS

- . ISO 14971 Application of Risk Management to Medical Devices
- . ISO 13485 Medical Devices - Quality Management Systems - Requirements For Regulatory purposes

#### 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 U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

# 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

JUL 20 2012

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

Re: K121948

Trade/Device Name: CR 10-X Digitizer Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: July 2, 2012 Received: July 3, 2012

### Dear Mr. Job:

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 ror association 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 uny 1 vith 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 mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirenchs as set forth in the quality of over as described in your Section 510(k) premarket whil anow you to ocgainmarketing your substantial equivalence of your device to a legally marketed nonication. The I Drice 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 desire specific davice of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 5456. Thise, productions are regarding the 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 Tou may other other geficiturers, 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 Form

510(k) Number (if known):

Device Name: CR 10-X Digitizer

### Indications for Use:

Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.

Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is 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 In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

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