MCA-601, C-ARM MOBILE

K993896 · Medison Radiology Systems, Inc. · JAA · Mar 27, 2000 · Radiology

Device Facts

• Record ID: K993896
• Device Name: MCA-601, C-ARM MOBILE
• Applicant: Medison Radiology Systems, Inc.
• Product Code: JAA · Radiology
• Decision Date: Mar 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Indications for Use

Producing fluoroscopic and general radiographic images for patient treatment and diagnosis. Especially being used during special procedures.

Device Story

The MCA-601 C-Arm Mobile X-Ray System consists of a high-frequency X-ray generator and an image intensifier mounted on a mobile C-arm base. The device is operated by healthcare professionals in hospitals or clinics to acquire real-time fluoroscopic and general radiographic images of patient anatomy. By providing immediate visual feedback during special procedures, the system eliminates the need for individual film development, assisting the attending physician in clinical decision-making and procedural guidance. The device is intended for diagnostic and treatment support.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-frequency X-ray generator; image intensifier; mobile C-arm transport base. Class II device.

Indications for Use

Indicated for providing fluoroscopic and radiographic images of patient anatomy during special procedures in hospitals or medical clinics.

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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# MAR 2 7 2000

## 510 (k) SUMMARY OF 21 CFR 807.92 FOR MODEL MCA-601 C-ARM MOBILE FLUOROSCOPIC SYSTEMS, IMAGE INTENSIFIED

x 993896

#### 1.0 Device Name :

Trade Name : C-Arm Mobile X-Ray Systems

#### 2.0 Reason for Submittal:

Model Name Change

- 3.0 Submitting Establishment :
Medison Radiology Systems, Inc 151 South Pfingsten Road, Unit V Deerfield, Illinois 60015

Establishment Registration No. : 1424247

Corresponding Official : John W. Lee, President 847 - 291 - 0999 Manufacturer : MedisonAcoma Co., Ltd 22-8, 3-Chome Hongo, Bunkyo-ku Tokyo, Japan

- 4.0 Panel and Device Classification :
Panel: Fluoroscopic Systems, Image Intensified Classification: II

- 5.0 Description:
High frequency X-ray generator and Image intensifier systems are mounted on C-arm transport mobile base. See Appendix "A" for the system configuration and labeling data.

- 6.0 Intended Use :
Producing fluoroscopic and general radiographic images for patient treatment and diagnosis. Especially being used during special procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2000

John W. Lee President Medison Radiology Systems, Inc. 151 South Pfingsten Road, Unit V Deerfield, IL 60015

Re:

K993896 MCA-601, C-Arm Mobile Dated: February 28, 2000 Received: March 1, 2000 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 892.1720/Procode: 90 IZL

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror to May 26, 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). 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Sood Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA 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 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions and allections of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitiled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510 (k) Number ( If known) : K993896 Device Name : MCA-601, C-arm mobile

### Indication of Use :

The MCA-601, C-Arm Mobile is used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics.

The fluoroscopic mode of operation is very useful to the attending physician to see the images in real time without the need to develop individual films.

( Please do not write below this line - continue on the another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801. 109)
OR
Over - The - Counter - Use
(Optional Format 1-2-9)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993896