(13 days)
No
The summary describes standard nuclear medicine imaging techniques and image enhancement features without mentioning AI or ML.
No
The device is used for diagnostic imaging procedures (detection of radioisotope tracer uptake), not for treating or preventing diseases.
Yes
The "Intended Use" section explicitly states that the system is designed for "detection of radioisotope tracer uptake in the patient body" and for use in "clinical diagnostic imaging applications."
No
The device description is not found, but the intended use and predicate devices clearly indicate a Nuclear Medicine imaging system, which is a hardware-based device. The mention of "assortment of collimators" further confirms the presence of hardware components.
Based on the provided information, the Quasar system is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body". This involves imaging the patient directly, not analyzing samples taken from the patient.
- Device Description (or lack thereof): While the description is "Not Found", the intended use and the type of imaging modality (Nuclear Medicine) strongly indicate an in-vivo imaging system.
- Input Imaging Modality: "Nuclear Medicine imaging procedures" are performed on the patient's body.
- Anatomical Site: "patient body" confirms it's used on a living organism.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. The Quasar system operates by detecting radiation emitted from a radioisotope tracer administered to the patient, which is an in-vivo process.
N/A
Intended Use / Indications for Use
The intended use of the Quasar 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 Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.
The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.
Product codes
90 KPS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine imaging (planar, tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET - also known as Coincidence Detection)), single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging.
Anatomical Site
Not Found
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)
Reference Device(s)
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
1022960
Image /page/0/Picture/1 description: The image shows a black and white logo of GE, which is a well-known multinational conglomerate. The logo is circular in shape and features the letters 'GE' intertwined in a stylized manner. The design is simple yet recognizable, representing the brand's identity.
SEP 1 9 2002
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, Wi 53201
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 10. 807.87(h))
Device Name Proprietary Device Name:
GE Quasar System
| Establishment Name and Registration Number of Submitter | |
|---|---|
| Name: | ELGEMS Ltd. |
| Date Prepared: | July 11, 2002, revised August 27, 2002 |
| Registration Number: | 9613299 |
| Corresponding Official: | Hemy Neuman, Quality, Safety and |
| Regulatory Manager | |
| ELGEMS Ltd. | |
| 10 Hayozma St. | |
| Tirat Hacarmel 30200, ISRAEL | |
| Hemy.neuman@med.ge.com | |
| Tel: +972-4-856-3667 | |
| Fax: +972-4-857-7664 | |
| Device Classification | |
| Classification Code: | 90 KPS |
| Panel Identification: | Radiology |
Emission Computed Tomography System Classification Name: (per 21CFR 892.1200) Nuclear Medicine Imaging system Common Name: Classification Class: Class II Product
Reason for 510(k) Submission Modification of legally marketed device.
Identification of Legally Marketed Equivalent Devices
Elscint Apex VariCam - K953801 GE Hawkeye Option for Dual-Head Variable Angle Gamma Camera -K991841 GE CoDe Option; Volumetric Coincidence Detection (CoDe) Imaging System
for VariCam (Nuclear Medicine System) - K962100
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the top of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
GE Medical Systems c/o Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K022960
Trade/Device Name: GE Quasar System Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: August 30, 2002 Received: September 6, 2002
Dear Mr. Steneberg:
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 (PMA), it may be subject to 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 electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
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), 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, 4xxx, 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 entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your 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,
Пенсу Сводки
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INTENDED USE
510(k) Number (if known):
Device Name: GE Quasar System
Indications for Use
The intended use of the Quasar 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 Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.
The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.
(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
Yimil le. Sagnm
(Division Sian-Off Division of Reproductive and Radiological Devices 510(k) Number