510K Brightspeed Series
510K Brightspeed Series
510K Brightspeed Series
(0) GE Healthcare
3000 N. Grandview Blvd, W-1 140
Waukesha, WI 53188
Submitter:
Name: GE Medical Systems, LLC (GE Healthcare)
Address: 3000 N. Grandview Blvd., W-1140
Waukesha, WI 53188
Contact: Steve Kachelmeyer
Premarket Regulatory Affairs Program Manager
Tel: 262-548-2432, Fax: 262-997-1080
e-mail: Steven.Kachelmeyer~med.ge.com
Date Prepared: August 11, 2008
PRODUCT IDENTIFICATION
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Marketed Devices: The GE BrightSpeed Delight series CT Scanner System (aka
GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed
Edge Select, and BrightSpeed Excel Select) is 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
similar intended uses, such as the previous StarSpeed CT
Scanners.
Predicate Device(s):
DEVICE DESCRIPTION
This device may include data and image processing to produce images in a variety of
trans-axial and reformatted planes. Further the images can be post processed to
produce additional imaging planes or analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole
body, cardiac and vascular X-ray Computed Tomography applications.
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The device output is a valuable medical tool for the diagnosis of disease, trauma, or
abnormality and for planning, guiding, and monitoring therapy.
Conclusions:
The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification
to the StarSpeed Series CT system (K052855). It does not result in any new potential
safety risks and performs as well as or better than devices currently on the market. The
GE BrightSpeed Delight Series CT system will be certified to comply with the X-ray
requirements of 21CFR 1020.30 and 1020.33, as well as the safety requirements of UL
60601-1, and IEC 60601-1 and associated collateral and particular standards. GE
considers the GE BrightSpeed Delight Series CT Scanner System to be equivalent to
other marketed devices with similar indications for use and meeting similar standards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Re: K082816
Trade/Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed
Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and
BrightSpeed Excel Select)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: II
Product Code: JAK
Dated: September 24, 2008
Received: September 25, 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
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.
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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 electronic product radiation
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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:
Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's
Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-
3474. For questions regarding the reporting of device adverse events (Medical Device Reporting
(MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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
(240) 276-3150 or at its Internet address http://www.fda.gov/edrh/industrv/support/index.html.
Sincerely yours,
Enclosure
Indications for Use
Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed Elite,
BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select)
The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-
sectional images of the body by computer reconstruction of x-ray transmission data taken at different
angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions.
These images may be obtained either with or without contrast. This device may include signal analysis
and display equipment, patient, and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and
reformatted planes. Further the images can be post processed to produce additional imaging planes or
analysis results.
The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and
vascular X-ray Computed Tomography applications.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for
planning, guiding, and monitoring therapy.
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(Dvision Sign-Oft)
Division of Reproductive, Abdominal,
and Radiological Deviches
510(k) Number_ _iau 4"/2
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