(15 days)
Not Found
Not Found
No
The device description lists standard radiographic components and there are no mentions of AI, ML, or image processing that would suggest the use of such technology.
No
The device is intended for generating radiographic images for diagnostic procedures, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Silhouette FC is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures."
No
The device description explicitly lists multiple hardware components (radiographic table, overhead suspension, generator, wall stand, x-ray tube, operator's console).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "generating radiographic images of human anatomy in all general purpose diagnostic procedures." This describes an imaging device used on the patient, not a device used to test samples from the patient (which is the definition of an in vitro diagnostic).
- Device Description: The components listed (radiographic table, overhead suspension, generator, x-ray tube, console) are all typical components of an X-ray imaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements associated with in vitro testing.
Therefore, the Silhouette FC is a radiographic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Silhouette FC is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Product codes
90 KPR
Device Description
The Silhouette FC consists of a radiographic table, a overhead suspension, high frequency generator and power tube distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
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
Not Found
Key Metrics
Not Found
Predicate Device(s):
Not Found
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.
0
K99 3090
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS OCT 1 1999
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).
Identification of Submitter: Larry A. Kroger, Ph.D. Senior Requiatory Programs Manager GE Medical Systems Tel. (414) 544-3894 Summary prepared: 28 August, 1999
- Silhouette FC Identification of Product: Classification Name: Stationary X-ray System GE HuaLun Medical Systems Co., Ltd. Manufacturer: No. 9 Wan Yuan Street Beijing Economic & Technological Development Area Beijing, 100176 P.R. China
- The Silhouette FC consists of a radiographic table, a overhead Device Description: suspension, high frequency generator and power tube distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
- The Silhouette FC is indicated for use in generating radiographic Indications for Use: images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- The Silhouette FC will conform the applicable sections of 21CFR Conformance 1020.30 and 1020.31, and UL 2601-1 (which includes IEC 601-1 and UL 187). The Silhouette FC also meets the IEC 601-1-2 standard for EMC.
- Conclusions: GE considers the Silhouette FC to be equivalent with other marketed devices with the same indications for use and meeting similar standards.
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
General Electric Medical Systems C/o Reiner Krumme TUV Reinland of North America 12 Commerce Road
1 1999
Re:
K993090 Silhouette FC Diagnostic X-Ray System Dated: August 31, 1999 Received: September 16, 1999 Regulatory Class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Mr. Krumme:
Newtown, CT 06470
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). 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 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 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 dassification 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,
CART Daniel R. Carlin, M.D.
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
Image /page/1/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation.
2
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Silhouette FC
Indications for Use -- -
The Silhouette FC is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of 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 | K993090 |