(29 days)
No
The summary describes a modified X-ray table with no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No.
The device is an X-ray table designed to support and position patients for diagnostic and interventional procedures, not to directly treat a medical condition.
No
The device is described as an X-ray table intended to support and position patients for angiographic examinations and interventional techniques. It is a support apparatus, not a device that directly performs diagnostic functions.
No
The device description clearly states it is a modification to an existing floor mounted X-ray table, indicating it is a hardware device.
Based on the provided information, the Siemens Koordinat Angiographic X-ray Table family is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for supporting and positioning patients during angiographic examinations, interventional techniques, and surgery. These are procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description confirms it's an X-ray table, a piece of equipment used in medical imaging and procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Koordinat table does not perform this function.
N/A
Intended Use / 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.
Product codes
90 IZI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951176, K883613, K940696, K884531
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
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.(b)
Classification. Class II.
0
DEC 21 1999
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: (908) 321-3243 Fax: (908)321-4841
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
1
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.
2
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.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
3
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) | |
|---|---|
| OR Over-The-Counter Use |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K993947 |