DIGITAL RADIOGRAPHY

K103591 · Canon Inc. -Medical Equipment Group · MQB · Mar 29, 2011 · Radiology

Device Facts

• Record ID: K103591
• Device Name: DIGITAL RADIOGRAPHY
• Applicant: Canon Inc. -Medical Equipment Group
• Product Code: MQB · Radiology
• Decision Date: Mar 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and DIGITAL CXDJ-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.

Device Story

The CXDI-401G/C and COMPACT models are solid-state X-ray imagers with a 41.5 x 42.6cm imaging area. The device intercepts X-ray photons; a scintillator (GOS for 401G models, CsI for 401C models) emits visible light; an array of photo-detectors converts this light into electrical signals; signals are digitized and displayed on monitors. Used in clinical settings for general radiographic examinations; operated by trained healthcare professionals. The device replaces traditional film/screen systems, providing digital images to assist clinicians in diagnostic decision-making.

Clinical Evidence

No clinical data. Performance testing was limited to bench testing, including electrical safety and electromagnetic compatibility assessments, to demonstrate substantial equivalence.

Technological Characteristics

Solid-state X-ray imager; 41.5 x 42.6cm imaging area. Scintillator materials: Gadolinium Oxy-Sulfide (GOS) for 401G models, Cesium Iodide (CsI) for 401C models. Converts X-ray photons to visible light, then to electrical signals via photo-detector array. Digital output. COMPACT models include specific housing for stand/table integration.

Indications for Use

Indicated for digital image capture in general purpose diagnostic radiographic procedures, replacing conventional film/screen systems. 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

• DIGITAL RADIOGRAPHY CXDI-70C Wireless (K102012)
• DIGITAL RADIOGRAPHY CXDI-40G COMPACT (K090623)
• DIGITAL RADIOGRAPHY CXDI-40EC (K062221)
• DIGITAL RADIOGRAPHY CXDI-40EG (K050987)

Submission Summary (Full Text)

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Section 5: 510(k) Summary

# K103591

# 510(k) Summary

MAR 2 9 2011

#### Prepared:

December 3, 2010

Tokyo 146-8501, Japan

30-2 Shimomaruko 3-chome, Ohta-ku

DIGITAL RADIOGRAPHY CXDI-401G DIGITAL RADIOGRAPHY CXDI-401C

Canon Inc.

Naoyasu Asaka

81-3-3758-2111

81-3-5482-3960

New Model

Canon Inc.

Submitter/Holder: Company Name:

Company Address:

Contact Person: Phone Number: Fax Number:

Proposed Device:

Reason For 510(k): Trade Name: Model Name:

Classification Name: FDA 510(k) #:

Predicate Device:

Trade Name: FDA 510(k) #/Model Name:

DIGITAL RADIOGRAPHY CXDI-401G COMPACT DIGITAL RADIOGRAPHY CXDI-401C COMPACT 90MQB, Solid State X-ray Imager To be assigned

Classification Name:

: K102012

Canon Inc.

K102012/ DIGITAL RADIOGRAPHY CXDI-70C Wireless K090623/ DIGITAL RADIOGRAPHY CXDI-40G COMPACT K062221/DIGITAL RADIOGRAPHY CXDI-40EC K050987/ DIGITAL RADIOGRAPHY CXD1-40EG 90MQB, Solid State X-ray Imager

### Description of Device:

The DIGITAL RADIOGRAPHY CXD1-401G CXD1-401C, CXD1-401G COMPACT and CXDI-401C COMPACT are solid state x-ray imagers which have 41.5 x 42.6cm imaging area. The device intercents x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.

The CXDI-401G and CXDI-401G COMPACT use GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-401C and CXDI-401C COMPACT use Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen.

The CXDI-401G COMPACT and CXDI-401C COMPACT employ housing for easy installation in stand unit and table unit.

Intended Use:

RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and DIGITAL CXDJ-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations.

These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

These devices are not intended for mammography applications.

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#### Section 5: 510(k) Summary

#### Comparison to Predicate:

The imaging principle and intended use of the DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT are the same as those of the predicate devices (CXD1-70C Wireless, CXD1-40G COMPACT, CXD1-40EC or CXD1-40EG).

### Performance testing:

The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.

#### Conclusion:

The Performance Data demonstrate that CXD1-401 G, CXD1-401 G, CXD1-401 G COMPACT and CXDI-401C COMPACT are as safe and effective as the predicate devices (DIGITAL RADIOGRAPHY CXDI-70C Wireless, CXDI-40G COMPACT, CXDI-40EC or CXDI-40EG), Based on the information in this submission, similarity to the predicate devices, and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RADIOGRAPHY CXDI-401G CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT described in this submission are substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's name in bold, uppercase letters. To the left of the text is a symbol that is part of the department's official branding.

Public Health Service

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

Canon, Inc. - Medical Equipment Group % Mr. Koji Kubo Manager Cosmos Corporation - Tokyo Office 3F 2-17-6 Akebono-cho TACHIKAWA-SHI TOKYO 190-0012 JAPAN

AUG 23 2013

Re: K103591

Trade/Device Name: CXDI-401G, CDXI-401C, CDXI-401G COMPACT and CDXI-401C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 25, 2011 Received: February 28, 2011

Dear Mr. Kubo:

This letter corrects our substantially equivalent letter of March 29, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(x) premier 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 encrosule) to regars analysis possible perice Amendments, or to comments to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices ulat have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Ret) market the device, subject to the general controls provisions of the Act. The Tou may, dicierore, market the devices, obly over equirements for annual registration, listing of general controls provisions of the lice, 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 If your device is classified (600 acorre) in the major regulations affecting your device can be found in Title 21, additional controls. Distant major regates 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 I lease be advised that I Dr I s issualled or our device complies with other requirements of the Act that I DA has made a doterimation administered by other Federal agencies. You must of any I edelal statutes and regulations and limited to: registration and listing (21 Compy with an the fict 6 requirements, 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse overse (OS) regulation (21 CFR Part 820). This letter requirements as set forth in the quality of cribed in your Section 510(k) premarket whil allow you to begin markemig your active as valence of your device to a legally marketed noutication. THC FDF Imaging of clestion 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 II you desire specific advice for your do novel cases graluation and Safety at [phone]. Also, please conce 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

under the MDR regulation (2) "CF FCT at 005), products/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 I ou may 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): _ L ( b 3 5 ]) CXDI-401G, CXDI-401C, CXDI-401G COMPACT, CXDI-401C COMPACT Device Name: Indications for Use: DIGITAL RADIOGRAPHY CXDI-401G, CXDI-401C, CXDI-401G COMPACT and CXDI-401C COMPACT provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications. OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE) Page 1 of 1 Division of Radiolo