(17 days)
No
The document describes standard CT scanner components and software for image acquisition and reconstruction, without mentioning any AI/ML capabilities or related performance metrics.
No
The device is described as a CT scanner system for X-ray Computed Tomography applications, which are diagnostic imaging procedures, not therapeutic treatments.
Yes
The device is a CT scanner, which acquires X-ray images of the body. These images are then used by medical professionals to diagnose various conditions in the head and whole body.
No
The device description explicitly states it is composed of hardware components (gantry, patient table, operator console, computer, PDU, image acquisition hardware) in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The StarSpeed Series CT Scanner System is an imaging device that uses X-rays to create images of the inside of the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for "head and whole body X-ray Computed Tomography applications," which is a form of medical imaging performed on the patient, not on a sample from the patient.
Therefore, based on the provided information, the StarSpeed Series CT Scanner System is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.
Product codes
JAK
Device Description
The StarSpeed Series CT Scanner Systems are composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system.
The StarSpeed Series is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 2601-1. IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Mentions image processing
Yes
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030420, K013561, K002978, K000300
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the alphanumeric string "K052855" in a bold, handwritten style. The characters are slightly slanted to the right, and the overall appearance suggests a quick or casual writing style. The contrast between the dark characters and the background is high, making the string easily readable.
321 2 8 2005
Image /page/0/Picture/2 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.
GE Healthcare
3000 N. Grandview Blvd. W-1140
Waukesha, WI 53188
AZ
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
Submitter: Lekshmi Nair FCT Safety and Regulatory Engineer Tel: 262-312-7415, Fax: 262-312-7369 e-mail: Lekshmi.Nair@med.ge.com Date Prepared: September 20, 2005
PRODUCT IDENTIFICATION
Name:
StarSpeed Series CT Scanner Systems
Classification Name:
Computed Tomography X-ray System 21CFR892.1750, 90-JAK
Manufacturer:
GE Medical Systems LLC (GE Healthcare) 3000 N. Grandview Blvd. Waukesha, WI 53188
GE YOKOGAWA MEDICAL SYSTEMS 7-127 Asahigaoka 4-chome Hino-shi, Tokyo, JAPAN 191
GE HANGWEI MEDICAL SYSTEMS CO., LTD. No.1, Yong Chang North rd. Beijing economic & technological development zone Beijing, PR CHINA 100176
Distributor:
Same as Manufacturer
Marketed Devices:
The StarSpeed Series CT Scanner Systems are of comparable type and substantially equivalent to GE's currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have the same intended uses, such as the previous LightSpeed CT Scanners.
1
DEVICE DESCRIPTION
The StarSpeed Series CT Scanner Systems are composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system.
The StarSpeed Series is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 2601-1. IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.
Indications for Use:
The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.
Comparison with Predicate:
StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system. It has the same technological characteristics and operating principles, is comparable in key safety and effectiveness and QA features, and uses the same basic design, construction, and materials.
In the opinion of GE Healthcare, the StarSpeed Series CT Scanner Systems are of comparable type and substantially equivalent to currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended uses. StarSpeed Series will be certified to comply with the X-ray requirements of 21CFR1020.30 and1020.33, as well as the safety requirements of UL2601-1, and IEC 60601-1 and associated collateral and particular standards.
Adverse Effects on Health:
Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analysis) and controlled by:
- System verification and validation to ensure performance to specifications. Federal ● Requlations, and user requirements.
- Adherence and certification to industry and international standards. (UL/CSA and IEC). ●
2
CONCLUSIONS
StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the latest features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system and does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the StarSpeed Series CT Scanner Systems to be equivalent to other marketed devices with the same indications for use and meeting similar standards.
A4
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo with an abstract bird design inside a circle. The bird is composed of three curved lines, suggesting movement or flight. The circle surrounding the bird contains text, though the specific words are not clear due to the image quality. There is also a vertical black bar on the left side of the image.
Public Health Service
OCT 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
General Electric Co. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K052855
Trade/Device Name: StarSpeed Series CT Scanner System Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 5, 2005 Received: October 11, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INTENDED USE
510(k) Number (if known): K052855
Device Name: StarSpeed Series CT Scanner System
Indications For Use:
The StarSpeed Series CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography 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 _
David R. Ingram
(Division Sign-Off) Division of Reproductive, and Radinlogical Device 510(k) Number
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