(72 days)
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Not Found
No
The summary describes a standard radiographic imaging system with no mention of AI or ML features in the intended use, device description, or other sections.
No
The device is described as generating radiographic images for diagnostic procedures, not for treating or preventing diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures."
No
The device description explicitly lists hardware components such as an integrated table, tube stand, generator, power distribution unit, wall stand, and x-ray tube.
Based on the provided information, the Silhouette VR is not an In Vitro Diagnostic (IVD) device.
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 hallmark of an IVD).
- Device Description: The components listed (table, tube stand, generator, wall stand, x-ray tube, console) are all typical of an X-ray imaging system, not an IVD.
- Input Imaging Modality: "Radiographic" is an imaging modality, not a method for analyzing biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue to diagnose diseases or other conditions. The Silhouette VR is an imaging device used to visualize internal structures of the body.
N/A
Intended Use / Indications for Use
The Silhouette VR is indicated 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 (comma separated list FDA assigned to the subject device)
90 KPR
Device Description
The Silhouette VR consists of an integrated table and tube stand, under-the-table generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human anatomy
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 4 1998 P O Box 414 Milwaukee WI 53201-041.
982955
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 Regulatory Programs Manager
GE Medical Systems
Tel. (414) 544-3894
Summary prepared: 7 August, 1998 |
| ------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Identification of Product: Silhouette VR
- Classification Name: Stationary X-ray System
- GE HuaLun Medical Systems Co., Ltd. Manufacturer: No. 11 Jiuzhong Road, Jiugong Zone. Daxing County, Beijing (100076) P.R. China
- The Silhouette VR consists of an integrated table and tube stand. Device Description: under-the-table generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator's console.
- Indications for Use: The Silhouette VR is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- The Silhouette VR 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 VR also meets the IEC 601-1-2 standard for EMC.
- GE considers the Silhouette VR to be equivalent with other Conclusions: marketed devices with the same indications for use and meeting similar standards.
1
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms, with three curved lines forming the body and arms. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 NOV
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 , W-709 Milwaukee, WI 53201
K982955 Silhouette VR Dated: August 21, 1998 Received: August 24, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR
Dear Dr. Kroger:
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 prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or 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 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/odrividsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INTENDED USE
510(k) Nun ber (if known): K982955
Device Name: Silhouette VR
Indications for Use
The Silhou ette VR is indicated for use in generating radiographic images of human anatomy in The Simot site VYT is Indicated for ass in generaling halls not intended for mammographic applicatior s.
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 | K982955 |