Who is the manufacturer of C-QUEST?

Medx, Inc. filed the 510(k) submission for C-QUEST (K082581).

What is the FDA product code for C-QUEST?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for C-QUEST?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like C-QUEST?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

C-QUEST

K082581 · Medx, Inc. · KPS · Nov 14, 2008 · Radiology

Device Facts

Record ID	K082581
Device Name	C-QUEST
Applicant	Medx, Inc.
Product Code	KPS · Radiology
Decision Date	Nov 14, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2

Intended Use

The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.

Device Story

C-Quest is a compact, dual-head dedicated cardiac scintillation camera system. It consists of an open gantry with a fixed 90-degree dual-head detector and a motorized patient table. The system detects gamma-ray emission radionuclides (60-170 keV) within the body. Inputs are processed via the NuQuest acquisition/processing computer or a handheld controller/touch screen. The system performs tomographic studies in circular or elliptical orbits, with or without gating, and supports planar static and dynamic studies. It produces cross-sectional, three-dimensional images through computer reconstruction. Used in clinical settings by healthcare professionals to visualize internal radionuclide distribution, aiding in the diagnosis of cardiac and non-cardiac conditions. Benefits include high-resolution imaging of metabolic processes to support clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technical performance specifications (spatial resolution, linearity, and uniformity) against the predicate device.

Technological Characteristics

Dual-head scintillation camera; NaI(Tl) crystal detectors; photomultiplier tubes (PMTs); motorized patient table (vertical/horizontal movement); energy range 60-170 keV; supports circular/elliptical tomographic orbits, gated/static/dynamic acquisition; NuQuest computer-based processing; standalone system.

Indications for Use

Indicated for diagnostic imaging of biochemical and metabolic processes in patients requiring cardiac multislice imaging, chest region, or body extremity procedures using gamma-ray emission radionuclides (60-170 keV).

Regulatory Classification

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.

Predicate Devices

Cardiocam (K011611)

Related Devices

K011611 — CARDIOCAM MODEL 9CSY0799 · Danish Diagnostic Development A/S · Jun 8, 2001
K030085 — CARDIUS-1 AND CARDIS-2 · Digirad Corp. · Feb 5, 2003
K021823 — CARDIOSPECT D90/CARDIO CAM · Nuclear Cardiology Systems, Inc. · Jun 17, 2002
K161740 — D-SPECT Scanner, D-SPECT L Scanner · Spectrum Dynamics Medical, Ltd. · Nov 4, 2016
K033199 — COMPACT DIGITAL CARDIAC CAMERA (CDCC) · Is2 Medical Systems, Inc. · Nov 12, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ KC 823-81 Submitter: MEDX C-Quest Premarket Notification: Traditional 510(k) ## 510(k) Summary # NOV 1 4 2008 | Submitter Name: | MEDX, Inc. | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 3456 N. Ridge Avenue, Suite 100 Arlington Heights, IL 60004 | | Establishment Reg. #: | 1419459 | | Phone Number: | 847.463.2020 | | Fax Number: | 847.463.2019 | | Contact Person: | Eric Ellingson | | Date Prepared: | 02 September 2008 | | Device Trade Name: | C-Quest System | | Common Name | Cardiac Gamma Camera System | | Classification Name, | Emission Computed Tomography System | | Number & Product Code: | 892.1200 KPS | | Predicate Devices: | Cardiocam | | Device Description and Statement of Intended Use | Device Description : A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen. Statement of Intended Use : C-Quest equipped with NuQuest (hereinafter referred to as C-Quest system) forms an emission computed tomography system intended to detect the location and distribution of gamma-ray emission radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. C-Quest system is primarily intended for cardiac applications, however the C-Quest system design also supports non-cardiac procedures of the patient's chest region and body extremities | | Summary of Technological | The C-Quest cardiology scintillation camera design comprises an open gantry supporting a fixed 90 degree dual head detector and a patient table. C-Quest is operated through interaction with an acquisition and | 05 002 a visua a visua viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viva viv : . {1}------------------------------------------------ | Characteristics | processing computer system (NuQuest), or the C-Quest's dedicated handheld controller or touch screen. The patient table can perform vertical and horizontal (along long axis) motor-driven movement for patient positioning. Tomographic studies can be performed in a circular or elliptical orbit with or without gating. Each detector head consists of a rectangular Nal(TI) crystal, photo-multiplier tubes (PMTs) and the detector electronics. Planar static and dynamic studies can be performed. The C-Quest system supports gamma-ray emission radionuclides within the energy range of 60 - 170 keV. | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | The information discussed above demonstrates that C-Quest system performs as well as the predicate device | | Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information | . : {2}------------------------------------------------ ## Summary of Technical Characteristics | Feature | C-Quest | Cardiocam K011611 | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | | | | Manufacturer | MEDX | DANISH DIAGNOSTIC DEVELOPMENT A/S | | Classification # & Product Code | KPS 892.1200 Emission computed tomography system | KPS 892.1200 Emission computed tomography system | | Intended Use | The C-Quest system is a dual head system designed to acquire data for cardiac multi-slice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic imaged of biochemical and metabolic processes using approved radionuclides within the range of 60 - 170 keV such asTc-99m, TI-201, or Co-57. | The Cardiocam system is a dual head system designed to acquire data for cardiac multi-slice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic imaged of biochemical and metabolic processes using Tc-99m, Ti-201, or Co-57. | | Mode of Action | Image acquisition of radioactive nucleotide distribution by scintillation cameras | Image acquisition of radioactive nucleotide distribution by scintillation cameras | | Design | Open gantry supporting a fixed 90 degree dual head detector and a patient table | Open gantry supporting a fixed 90 degree dual head detector and a patient table | | Method of Operation | Operated through interaction with an acquisition and processing computer system | Operated through interaction with an acquisition and processing computer system | | Intrinsic spatial resolution - Center FOV | FWHM: ≤3.5mm FWTM: ≤7.4mm | FWHM: ≤2.8mm FWTM: ≤2.9mm | | Intrinsic spatial resolution - Useful FOV | FWHM: ≤3.7mm FWTM: ≤7.6mm | FWHM: ≤5.4mm FWTM: ≤5.6mm | | Intrinsic Spatial Linearity - Center FOV | Differential: ≤0.4mm Integral: ≤0.8mm | Differential: 0.18mm Integral 0.38mm | | Intrinsic Spatial Linearity - Useful FOV | Differential: ≤0.5mm Integral: ≤1.0mm | Differential: 0.20mm Integral: 0.40mm | | Intrinsic Uniformity - Center FOV | Integral: +/- 2.5% Differential: +/- 1.5% | Integral: +/- 2.4% Differential: +/- 1.9% | | Intrinsic Uniformity - Useful FOV | Integral: +/- 3.0% Differential: +/- 2.0% | Integral: +/- 2.9% Differential: +/- 2.4% | 11 : {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MEDX, Inc. % Mr. William Greenrose President & CEO Oserve America, Inc. 220 River Road CLAREMONT NH 03743 NOV 1 4 2008 Re: K082581 Trade/Device Name: C-Quest Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 2, 2008 Received: September 5, 2008 Dear Mr. Greenrose: 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 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. {4}------------------------------------------------ ## Page 2 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: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | 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/cdrh/industry/support/index.html. Sincerely vours. hope Mr. thang Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ : #### 4.1 Indications for Use Statement 510(k) Number (if known): K08258/ Device Name: C-Quest Indications for Use: The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201. (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 (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices, 510(k) Number K082581 Section 4.0 CONFIDENTIAL