(14 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the combination of existing technologies for attenuation correction and image fusion.
No
The device is described as an imaging system used for diagnostic purposes (detection of radioisotope tracer uptake, CT applications, functional and anatomical mapping imaging), not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "detection of radioisotope tracer uptake in the patient body... in oncology, cardiology, neurology and other clinical diagnostic imaging applications." This directly indicates a diagnostic purpose.
No
The device description explicitly states that the "Infinia LightSpeed" system is a combination of two physical scanners: the Infinia NM Scanner and the "LightSpeed" 5 CT Scanner. This indicates the device includes significant hardware components, not just software.
Based on the provided information, the "Infinia LightSpeed" system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Infinia LightSpeed system performs imaging procedures on the patient body using radioisotope tracers and X-rays. It does not analyze samples like blood, urine, or tissue outside of the body.
- The system is a combination of imaging scanners. It's a SPECT/CT system, which are modalities used for in-vivo imaging, not in-vitro analysis.
The device is a medical imaging system used for diagnostic purposes within the patient's body.
N/A
Intended Use / Indications for Use
The intended use of the "Infinia LightSpeed" system is to perform:
- General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
- General Head & Body computed tomography (CT) applications. ◆
- Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).
Product codes (comma separated list FDA assigned to the subject device)
90 KPS, 90 JAK
Device Description
The "Infinia LightSpeed" system is a combination of the Infinia NM Scanner (K022960 & K991841) and the "LightSpeed" 5 CT Scanner (K030420). In addition to providing CT and NM standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the NM images and to facilitate localization of the emission activity in the patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography, Single Photon Emission Computed Tomography
Anatomical Site
Head & Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Phantom data shows that SPECT/CT attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the SPECT/CT.
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
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
DEC 2 3 2004
K043381
Page 1 of 2
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b) 10.
| Device Name | |
|---|---|
| Proprietary Device Name: | Infinia LightSpeed |
| Establishment Name and Registration Number of Submitter | |
| Name: | GE MEDICAL SYSTEMS F.I, HAIFA |
| Registration Number: | 9613299 |
| Corresponding Official: | Laurence Bigio |
| GE MEDICAL SYSTEMS F.I, HAIFA | |
| P.O. Box 170 | |
| Tirat Hacarmel 30200, ISRAEL | |
| Device Classification | |
| Classification Code: | 90 KPS & 90 JAK |
| Panel Identification: | Radiology |
| Classification Name: | System Emission Computed Tomography (per |
| 21CFR 892.1200) | |
| System Computed Tomography | |
| (per 21CFR 892.1750) | |
| Common Name: | Single Photon Emission Computed Tomography |
| Computed Tomography X-Ray | |
| Classification Class: | Class II Product |
Performance standards:
- Code of Federal Regulations Title 21 Subchapter J- Radiological Health -. 21CFR1020.30, 21CFR 1020.33.
- NEMA NU 1-2001. ●
- . IEC60601-1 and associated collateral and particular standards.
Reason for 510(k) Submission
Modifications of legally marketed devices.
Identification of Legally Marketed Equivalent Devices
| GE Quasar Nuclear Medicine System ("Infinia") | K022960 |
|---|---|
| "LightSpeed" 5.0 Computed Tomography System | K030420 |
| Hawkeye Option for Dual Head Variable Angle Gamma Camera | K991841 |
Device Description
The "Infinia LightSpeed" system is a combination of the Infinia NM Scanner (K022960 & K991841) and the "LightSpeed" 5 CT Scanner (K030420). In addition to providing CT and NM standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the NM images and to facilitate localization of the emission activity in the patient anatomy.
1
K043381
Page 2 of 2
Description of Change or Modification
The Infinia Scanner (K022960) has been modified to accommodate for the CT subsystem, by including a means to align the gantries, a common table and additional software for use of CT for purposes of attenuation correction.
Intended Use of Device
The intended use of the "Infinia LightSpeed" system is to perform:
- General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
- General Head & Body computed tomography (CT) applications. ●
- Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).
Summary of Studies
Phantom data shows that SPECT/CT attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the SPECT/CT.
Conclusion
In the opinion of GE MEDICAL SYSTEMS F.I., HAIFA the "Infinia LightSpeed" is substantially equivalent in terms of safety and effectiveness to the legally marketed Infinia (K022960) equipped with the Hawkeye option (K991841) and to the legally marketed LightSpeed 5.0 (K030420), based upon similar intended use and system performances.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes across its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
GE Medical Systems F.I. HAIFA (9613299) % Mr. Alex Grob Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
Re: K043381
Trade/Device Name: Infinia LightSpeed Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 KPS and JAK Dated: December 6, 2004 Received: December 9, 2004
Dear Mr. Grob:
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 reasy 2019, 11:53 am 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 do inc. require apperal 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 roderal batered and 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.
3
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/dsma/dsmamain.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
4
STATEMENT OF INTENDED USE
K 043381
510(k) Number (if known):
Device Name: Infinia LightSpeed
Indications for Use
The intended use of the "Infinia LightSpeed" system is to perform:
- General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.
- General Head & Body computed tomography (CT) applications. ◆
- Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).
(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,
and Radiological Devices
510(k) Number_________________
Infinia LightSpeed 510k Nov30.doc
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