(15 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices. The description focuses on standard CT scanner components and safety compliance.
No.
The device is a CT scanner, which is used for diagnostic imaging (acquiring images) rather than providing therapy (treating a condition). Its intended use is described for "X-ray computed tomography applications."
Yes
Explanation: The device is a CT scanner system, which is used to acquire images for diagnostic purposes. The "Intended Use / Indications for Use" states it is for "computed tomography applications," which is a diagnostic imaging technique.
No
The device description explicitly lists hardware components such as a gantry, patient table, image acquisition hardware, and an operator console, indicating it is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "head and whole body X-ray computed tomography applications." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The description details the components of a CT scanner (gantry, table, console, etc.), which are typical for an imaging system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This document does not mention any analysis of biological specimens.
The LightSpeed Plus CT Scanner System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.
Product codes (comma separated list FDA assigned to the subject device)
90-JAK
Device Description
The GE LightSpeed Plus Mobile CT Scanner System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Plus CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray computed tomography
Anatomical Site
head and whole body
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)
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. 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
Special 510(k) Premarket Notification GE Medical Systems - LightSpeed Plus Mobile CT System August 22, 2001
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and has a vintage look.
SEP = 7 2001
KO)2836
GE Medical Systems
P.O. Box 414, NB-918 Milwaukee, WI 53201
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Senior Regulatory Programs Manager
Telephone: 262-544-3894; Fax: 262-544-3863 |
| Date Prepared: | August 22, 2001 |
| Device Name: | LightSpeed Plus Mobile Computed Tomography System.
Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK |
| Marketed Device: | GE Medical System's LightSpeed Plus Computed Tomography System;
510(k) Number K000300, currently in commercial distribution. |
Device Description:
The GE LightSpeed Plus Mobile CT Scanner System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Plus CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.
Indications for Use:
The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray computed tomography applications. It can be operated in a mobile as well as a fixed site environment.
Comparison with Predicate Device:
The GE LightSpeed Plus Mobile Computed Tomography System is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed Plus CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.
Summary of Studies:
The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.
Conclusion:
Intended use and fundamental scientific technology are the legally marketed GE LightSpeed Plus CT System. The design and development process of the manufacturer conforms with 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the LightSpeed Plus Mobile CT System is substantially equivalent to the currently cleared LightSpeed Plus CT System.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, with flowing lines connecting them. The symbol is positioned in the upper right quadrant of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 7 2001
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, NB-918 MILWAUKEE WI 53201
Re: K012836
LightSpeed Plus Mobil CT System (Computed Tomography X-Ray System) Dated: August 22, 2001 Received: August 23, 2001 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Dr. Kroger:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the interest we nave revelved your Section 10(k) notication of their to make as a legally marketed predicate devices marked in interstated in substantially equivalent (or the motions to the Medical Device Amendments, or to devices that have been reclassified in commerce probl to May 28, 1970, the clasment and of the real of the et (Act). You may, therefore, market the besigniture accordance will the provisions of the Post, 2004, 2005 and s provisions of the Act include requirements for annual registration, the general controls provisions of the rice, 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 subject to subject to subject to subject to subject to subject to su If your device is classilied (see above) more cass II (opedia Oone of Federal Regulations, Title 21, Partical Regulario Personal additional controls. Existing major regulations articles with the Current Good Manufacturing Practice requirements, 800 to 897. A substantaly equivalian assumination assumers of man and manufacturer (21 CFR Part 820) and the children may as set form in the Quality System Regulation (QS) to Medical Derices. Failure to comply with the UMP regulation may QS Inspections, the Food alle Drig Ammisstanon (1 Dr.) Virther announcements concerning your device in the Federal Register. Please result if regulation in addition rumission submission does not affect any obligation you might have under setions 531 through nove. uns response to your premation babinessen assomes on 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 the post I fills letter will allow your device to a legally marked 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4,xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 and all a reference to premarket notification" (21 CFR 807.97). Other general Alst, please not responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C brogdon
Nancy C. Bk ogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Special 510(k) Premarket Notification Special 510(K) Premarket Notifioution
GE Medical Systems - LightSpeed Plus Mobile CT System August 22, 2001
STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LightSpeed Plus Mobile CT System
Indications for Use
The LightSpeed Plus CT Scanner System is indicated for head and whole body X-ray
the states and while the subservation and as answere as a fixed The LightSpeed Plus CT Scanner System is indication for house of the mobile as well as a fixed site environment.
(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_
Nancy broaden
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012836
510(k) Number.