LC POSITIONER

K981414 · Fischer Imaging Corp. · JAA · Jul 16, 1998 · Radiology

Device Facts

• Record ID: K981414
• Device Name: LC POSITIONER
• Applicant: Fischer Imaging Corp.
• Product Code: JAA · Radiology
• Decision Date: Jul 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.

Device Story

The LC Positioner functions as an accessory to a fluoroscopic C-arm unit. It is designed to assist in the positioning of the imaging system during cardiovascular imaging procedures. Used in clinical settings, such as an OR or imaging suite, by trained medical personnel (physicians/technicians). The device facilitates the alignment of the fluoroscopic unit to capture images of the cardiovascular system, aiding in diagnostic visualization. It does not perform image processing or analysis itself but supports the mechanical positioning of the primary imaging equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical accessory for fluoroscopic C-arm units. No electronic, software, or energy-emitting components described. Designed for physical positioning of imaging hardware.

Indications for Use

Indicated for use as an accessory to a fluoroscopic unit for imaging the cardiovascular system in patients requiring such diagnostic procedures.

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 9200 Corporate Boulevard Rockville MD 20850

Jul 1 6 1998

Director, Regulatory Affairs/Quality Assurance

K981414 LC Positioner (Fluoro C-Arm) March 31, 1998 Dated: Received: April 20, 1998 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA

Dear Ms. Emrich:

Samuella D. Emrich

Fischer Imaging Corp.

12300 North Grant Street

Denver, CO 80241-3120

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 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). 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 probibitions against misbranding and adulteration.

Re:

If your device is classified (see above) into either class II (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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product 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 on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT A

Initial 510(k)

K98/4/4

Device Name: Indications for Use: LC Positioner The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

or Over-the-Counter Use ______________________________________________________________________________________________________________________________________________________

(per 21 CFR 801.109)

David C. Began
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number