E.CAM COMPUTER

K992731 · Siemens Medical Solutions USA, Inc. · KPS · Nov 10, 1999 · Radiology

Device Facts

• Record ID: K992731
• Device Name: E.CAM COMPUTER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following techniques: - Planar Imaging ● - . Whole body imaging - Tomographic imaging (SPECT) for non positron emitter . - Positron imaging by coincidence . - Positron imaging without coincidence up to 588 keV .

Device Story

E.CAM Computer is an emission tomography system used to process and display radionuclide distribution data. It accepts inputs from nuclear medicine imaging modalities, including planar, whole body, and SPECT scans, as well as positron imaging. The system transforms these signals into diagnostic images for clinical review. Operated by trained medical personnel in clinical settings, the device assists physicians in visualizing physiological processes. The output enables clinicians to assess organ function and pathology, supporting diagnostic decision-making and patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Emission tomography computer system for processing radionuclide imaging data. Supports planar, whole body, SPECT, and positron imaging modalities. Connectivity and specific hardware architecture not detailed. Software-based processing of nuclear medicine signals.

Indications for Use

Indicated for patients requiring radionuclide imaging, including planar, whole body, and tomographic (SPECT) imaging, as well as positron imaging with or without coincidence (up to 588 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

• E.CAM (IP-500, K952109)
• ICON (K903315B)
• ADAC Pegasys (K892358)

Submission Summary (Full Text)

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K992731

# Summary Of Safety and Effectiveness

| Classification Name: | Emission Computed Tomography System |
|------------------------|---------------------------------------|
| Classification Number: | 21 CFR 892.1200 |
| Class of Device: | II |
| Common/Usual Name: | Emission tomography system (Computer) |
| Device Trade Name: | E.CAM Computer |

Intended Use: To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

- Planar Imaging ●
- . Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter .
- Positron imaging by coincidence .
- Positron imaging without coincidence up to 588 keV .

| Establishment Name<br>and Address: | Siemens Medical Systems, Inc.<br>Nuclear Medicine Group<br>2501 North Barrington Road<br>Hoffman Estates, IL 60195-5203 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 1423253 (Owner/Operator 9010023) |
| Performance Standard: | None established under Section 514 of The<br>Food. Drug and Cosmetic Act |

### II Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

### General Safety and Effectiveness Concerns:

The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.

#### Substantial Equivalence:

Siemens Medical Systems, Inc., Nuclear Medicine Group, believes that within the meaning of the Safe Medical Device Act of 1990 and the Medical Device Amendments of 1992 the E.CAM Computer, Emission Tomography System (Computer) is substantially equivalent to the currently marketed by Siemens Medical Systems, Inc., Nuclear Medicine Group, E.CAM (IP-500, K952109) and ICON (K903315B) and ADAC Pegasys (K892358).

#### Contact:

- Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. Nuclear Medicine Group 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Phone: [phone] Fax: [phone] [e-mail]

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, one behind the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Re:

K992731 E.CAM Computer Dated: August 12, 1999 Received: August 13, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Callahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have defermined 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in a regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known)_K 99273/

Device Name: E.CAM Computer, Emission Tomography System (Computer)

Indication for Use: To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

- Planar İmaging .
- . Whole body imaging
- Tomographic imaging (SPECT) for non positron emitter .
- . Positron imaging by coincidence
- . Positron imaging without coincidence up to 588 keV

PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH, Office of Device Evaluation (ODE)

David A. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT. and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Or

Over-The-Counter Use