SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200

K043379 · Shimadzu Corp. · OXO · Feb 17, 2005 · Radiology

Device Facts

• Record ID: K043379
• Device Name: SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
• Applicant: Shimadzu Corp.
• Product Code: OXO · Radiology
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The device is a Surgical Mobile C-arm Imaging X-ray System and allows a technician to examine a patient by fluoroscopy or radiography. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations.

Device Story

WHA-200 is a mobile C-arm X-ray system for fluoroscopy and radiography. Operated by physicians and X-ray technologists in clinical settings. Device captures X-ray images of patients; provides real-time visualization for diagnostic or interventional procedures. Output displayed on system monitors for clinical decision-making. Benefits include mobile imaging capability for surgical or diagnostic environments.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Mobile C-arm X-ray system; image-intensified fluoroscopy and radiography. Classified under 21 CFR 892.1650 (Product Code: OXO).

Indications for Use

Indicated for total patient populations requiring fluoroscopic or radiographic examination via a mobile C-arm X-ray system. Operated by physicians and X-ray technologists.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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

Shimadzu Corporation % Mr. Randal Walker X-ray Tech Support Manager Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328

NOV 1 4 2011

Re: K043379

Trade/Device Name: Surgical Mobile C-arm Imaging Z-ray System WHA-200 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: November 22, 2004 Received: December 30, 2004

Dear Mr. Walker:

This letter corrects our substantially equivalent letter of February 17, 2005.

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 (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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely Yours,

Michael D'Onofrio, Can

Mary S. Pastel, Sc.D. 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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## SECTION XI: INDICATION FOR USE STATEMENT

510(K) Number (if known): Unknown K043379

Device Name: WHA-200

Indications for Use:

- · The device is a Surgical Mobile C-arm Imaging X-ray System and allows a technician to examine a patient by fluoroscopy or radiography.
- · This device is operated and used by Physicians and X-ray technologist.
- · The object of this device is total patient populations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per2l CFR8O1.109)

OR

Over-The-Counter Use

Laird G. Bryson

(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 519(k) Number

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