GE DISCOVERY NM/CT 570C

K083504 · Ge Medical Systems F.I. Haifa · KPS · Dec 12, 2008 · Radiology

Device Facts

• Record ID: K083504
• Device Name: GE DISCOVERY NM/CT 570C
• Applicant: Ge Medical Systems F.I. Haifa
• Product Code: KPS · Radiology
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion). The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

Device Story

GE Discovery NM/CT 570c is a hybrid imaging system combining Ventri 1.1 SPECT scanner and LightSpeed 7.1 CT scanner; shares common patient table, gantry alignment, and emergency stop circuits. Inputs: SPECT radioisotope tracer emissions and CT X-ray attenuation data. Operation: CT images used for non-uniform attenuation correction of SPECT images and functional-anatomical mapping (registration/fusion). Used in clinical settings by trained medical professionals. Output: Integrated SPECT-CT diagnostic images. Benefits: Improved image uniformity via attenuation correction and precise anatomical localization of emission activity. Healthcare providers use fused images for diagnostic decision-making.

Clinical Evidence

Bench testing only. Data acquired with a uniform phantom demonstrated that SPECT-CT attenuation-corrected images exhibit higher uniformity than SPECT images without attenuation correction. Testing confirmed the system's capability for functional-anatomical localization.

Technological Characteristics

Hybrid SPECT-CT system. Components: Ventri 1.1 SPECT scanner, LightSpeed 7.1 CT scanner. Shared patient table, aligned gantries, integrated emergency stop circuits. Software-based attenuation correction and image registration/fusion. Energy sources: X-ray (CT) and radioisotope emissions (SPECT).

Indications for Use

Indicated for patients requiring nuclear cardiac imaging for detection/imaging of radioisotope tracer uptake and patients requiring general Head & Body Computed Tomography (CT) diagnostic imaging.

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

• Ventri 1.1 (K080124)
• LightSpeed 7.1 (K061817)
• Xeleris 2 (K051673)
• Infinia LightSpeed (K043381)

Submission Summary (Full Text)

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K083504

DEC 1 2 2008

#### 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)) 10.

#### Summary Date

September 4, 2008

## Device Name

Proprietary Device Name: GE Discovery NM/CT 570c

### Establishment Name and Registration Number of Submitter

Name: Registration Number: Corresponding Official:

GE MEDICAL SYSTEMS F.I. HAIFA 9613299 Laurence Bigio; Site QA Manager GE Medical Systems F.I. Haifa 4 Hayozma St. P.O. Box 170 Tirat Hacarmel 30200 ISRAEL Laurence.bigio(@med.ge.com [phone] (Tel) [phone] (Fax)

#### Device Classification

Classification Name:

Common Name:

Classification Code: Panel Identification: Classification Class:

System Emission Computed Tomography (per 21CFR 892.1200) System Computed Tomography (per 21CFR 892.1750) Single Photon Emission Computed Tomography Computed Tomography X-Ray 90 KPS & 90 JAK Radiology Class II Product

#### Type of Submission

Traditional

#### Reason for 510(k) Submission

Modification of legally marketed devices.

#### Identification of Legally Marketed Equivalent Devices

| Device Name | K Number | Feature |
|--------------------|----------|------------------------------------------------------------------------|
| Ventri 1.1 | K080124 | SPECT system |
| LightSpeed 7.1 | K061817 | CT system |
| Xeleris 2 | K051673 | Processing and Review Workstation for<br>SPECT, CT and Hybrid SPECT-CT |
| Infinia LightSpeed | K043381 | Hybrid SPECT-CT |

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# 510(k) Summary of Safety and Effectiveness, GE Discovery NM/CT 570c, Page 2

### Device Description

The GE Discovery NM/CT 570c system is a back-to-back combination of the Ventri 1.1 SPECT scanner (K080124) and the LightSpeed 7.1 CT scanner (K061817), sharing a common LightSpeed 7.1 patient table. In addition to providing CT and SPECT standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the SPECT images and to facilitate localization of the emission activity in the patient anatomy.

# Description of Change or Modification

The LightSpeed 7.1 CT System (K061817), the Ventri 1.1 SPECT System (K080124) and the Xeleris 2 Processing and Review Workstation (K051673), had been modified to accommodate for the GE Discovery NM/CT 570c system, by including means to align gantries, share emergency stop circuits, a common table and additional processing software for use of CT for purposes of SPECT attenuation correction.

## Intended Use of Device

The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion).

The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

### Summary of Studies

Data acquired with uniform phantom shows that SPECT-CT attenuation-corrected images are more uniform than SPECT 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 GE Discovery NM/CT 570c system is substantially equivalent in terms of safety and effectiveness to the legally marketed Ventri 1.1 (K080124), the legally marketed LightSpeed 7.1 (K061817), the legally marketed Infinia LightSpeed (K061817) and the legally marketed Xeleris 2 Processing and Review Workstation (K051673), based upon similar intended use and system performances.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**DEC 12 2008**

GE Medical Systems F.I. Haifa % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K083504

Trade/Device Name: GE Discovery NM/CT 570c Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: November 24, 2008 Received: November 26, 2008

# Dear Mr. Devine:

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.

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#### 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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jorpe In Whang

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

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### Indications for Use

510(k) Number (if known): _K 083504

Device Name: GE Discovery NM/CT 570c

Indications for Use:

The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion).

The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of racer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------|---------------|
| Division of Reproductive, Abdominal and Radiological Devices | Page __ of __ |
| (Posted November 13, 2003) | |
| 510(k) Number | K083504 |

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