KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY

K993947 · Siemens Corp. · IZI · Dec 21, 1999 · Radiology

Device Facts

• Record ID: K993947
• Device Name: KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
• Applicant: Siemens Corp.
• Product Code: IZI · Radiology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Indications for Use

The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

Device Story

The Koordinat Angiographic and Operating Room Model X-Ray Table family is a floor-mounted table designed to support and position patients during angiographic procedures and surgery. The device features an X-ray translucent tabletop to facilitate imaging. It is operated by clinical staff in angiographic suites or operating rooms. The system integrates with existing angiographic X-ray systems (e.g., Angiostar Plus, Multistar Plus). Higher-end models utilize a CAN bus interface to communicate table position data to the X-ray system and receive movement commands, replacing older analog interfaces. This integration allows for automated coordination between table positioning and X-ray imaging, assisting clinicians in performing interventions and surgeries with improved workflow and precision.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Floor-mounted X-ray table with X-ray translucent tabletop. Connectivity via CAN bus interface for position reporting and movement control in higher models; legacy analog interface support retained. Designed for integration with angiographic X-ray systems.

Indications for Use

Indicated for patients requiring support and positioning during angiographic examinations, interventional techniques, or surgical procedures where an X-ray translucent tabletop is necessary.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Koordinat M Table (K951176)
• OP/PTCA-System 1520 (K883613)
• Synchra Tilt (K940696)
• 90/50 Mobile Imaging Table (K884531)

Submission Summary (Full Text)

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DEC 21 1999

K993947

# Attachment 11

# 510 (k) Summary

Koordinat Angiographic and Operating Room Model X-Ray Table Family

Submitted by: Siemens Medical Systems, Inc. 186 Wood Ave South Iselin, NJ 08830

November 22, 1999

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

### 1. Contact Person

Ms Alicia Juergensen Phone: [phone] Fax: [phone]

### 2. Device Name and Classification:

Trade Name:

Classification Name: Classification Panel: CFR Section: Device Class:

Koordinat Angiographic and Operating Room Model X-Ray Table Family Angio X-Ray System Accessory Radiology 21 CFR §892.1600 Class II

### 3. Intended Use:

The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

## 4. Substantial Equivalence:

The new Koordinat OR models are substantially equivalent to the following device in commercial distribution:

- Koordinat M Table, K951176 cleared on 4/30/95 . Siemens Medical Systems, Inc.
- . OP/PTCA-System 1520, K883613 cleared on 9/15/88 Maquet
- Synchra Tilt, K940696 cleared on Philips
- t 90/50 Mobile Imaging Table, K884531 cleared on1/11/89 Beta Medical System

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### 5. Device Description

The Koordinat Table family is a modification to an existing floor mounted X-ray table for angiographic examinations and interventions, and surgery. The modified Koordinat table is based on knowledge and experience gained with the predecessor model, the Koordinat M Table. The Koordinat M was described in the 510(k) Submitted on 4/30/95 with the number K951176.

#### Summary of Technological Characteristics of the Principal Device as Compared with the 6. Predicate Device

The Kordinat Table has the same technological characteristics as the predicate Koordinat M table. Like the Koordinat M the Koordinat OR family can be connected to several existing angiographic xray systems (i.e. Angiostar Plus and Multistar Plus).

The difference is demonstrated in the higher two models which will no longer utilize analog interface but will provide a CAN bus interface to report table position to the angiographic x-ray system. Table movements will also be controlled via the CAN bus interface.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Alicia Juergensen Technical Specialist

Regulatory Affairs

Iselin, NJ 08830

Siemens Medical Systems, Inc.

186 Wood Avenue South

Re:

Kooridinat OR, AXIUM, AXIOM OR Angiographic and Operating Room Model X-Ray Table Family Dated: November 19, 1999 Received: November 22, 1999 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

Dear Ms. Juergensen:

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 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 prohibitions against misbranding and adulteration.

K993947

If vour 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 Requlations, 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 (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 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/dsma/dsmamain.html".

Sincerely yours,
Dan Stet

CAPT Daniel G. Schultz, M.D. Acting 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 1

# Indications for Use

K993947 510(k) Number (if known):

Device Name: __ Koordinat Angiographic X-Ray Table____________________________________________________________________________________________________________________________

Indications for Use:

The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for I he ordinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

| Prescription Use (per 21 CFR 801.109) | <div> <span></span> </div> |
|---------------------------------------|----------------------------|
| OR Over-The-Counter Use | <span></span> |

| (Division Sign-Off) | <span></span> |
|--------------------------------------------------------------------|---------------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | <span></span> |
| 510(k) Number | K993947 |