COREGISTRATION FUNCTION

K972451 · Nomos Corp. · IYE · Jan 22, 1998 · Radiology

Device Facts

• Record ID: K972451
• Device Name: COREGISTRATION FUNCTION
• Applicant: Nomos Corp.
• Product Code: IYE · Radiology
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system. The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.

Device Story

Coregistration function is a software module integrated into RT planning systems (e.g., CORVUS). It accepts multiple medical image sets as input, regardless of scanning modality. The device performs image registration to align complementary image data with CT scans, preserving geometric accuracy and tissue density information. Used in clinical settings by radiation oncology staff to facilitate treatment planning. By enabling the fusion of multi-modal data, it allows clinicians to visualize and integrate diverse diagnostic information, potentially improving the precision of radiation therapy planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image registration module for RT planning systems. Operates as an add-on to existing planning software. No specific hardware or material requirements. Connectivity is integrated within the host RT planning system environment.

Indications for Use

Indicated for patients undergoing radiation therapy (RT) planning who require correlation of multiple medical imaging modalities or registration of historical patient scans to current CT data to support treatment planning.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)

Reference Devices

• CORVUS (PEACOCK Plan) (K940663)

Submission Summary (Full Text)

{0}------------------------------------------------

972451
JAN.22, 1998

# ry of Safety and Effectivenes I) of the Federal Food, Drug and Cosmetic Compliance w

June 27, 1997

#### General Provisions 1.

Common/Usual Name Image Correlation System Proprietary Name Coregistration function Applicant Name and Address NOMOS Corporation 2591 Wexford Bavne Road

#### Name of Predicate Devices 2.

ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)'

Sewickley, PA 15143

#### 3. Classification

]

CORVUS™ (Cleared as PEACOCK® Plan (K940663) is classified as class II devices according to 21 CFR 882.5050 (90 IYE). These devices are reviewed by the Radiological Devices Panel of the Reproductive, Abdominal, Ear, Nose, and Throat and Radiological Division of the Office of Device Evaluation.

The predicate Radionics ImageFusion Software is unclassified by FDA but was grouped in LLZ with no CFR designation by the Radiological Devices Division.

## 4. Performance Standards

Performance standards for treatment planning systems have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

{1}------------------------------------------------

## re Intended Use and Device Description

The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.

The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.

## 6. Biocompatibility

Not applicable.

## 7. Summary of Substantial Equivalence

This device is similar in design, intended use and performance characteristics to the predicate devices. Testing shows that the device meets similar performance specifications as those for the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/1 description: The image shows a logo with a circular shape on the lower left and a stylized bird-like figure on the upper right. The text "DEPARTMENT OF HEALTH &" is arranged in a curved manner around the top and right side of the circle. The logo appears to be a vintage or older design, possibly representing a health organization or government department.

DEPARTMENT OF HEATTH & HUMAN SERVICE:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Marvin L. Sussman, Ph.D. Vice President Product Assurance NOMOS Corporation 2591 Wexford Bayne Road Suite 400 Sewickley, PA 15143

Re: K972451

> Coregistration Function Dated: October 27, 1997 Received: October 28, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Dr. Sussman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 fequirement, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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/dsmamain.html".

Sincerely yours.

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known)

Device Name: Coregistration

Indications for Use:

能

The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system.

The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue ............ density information from the CT.

(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)

Ekinl A. Seysson

Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devjo 510(k) Number

Image /page/3/Picture/12 description: The image is completely white and contains no discernible content. It is a blank canvas with no objects, shapes, or colors present. The image appears to be a solid white background. There are no visible details or features in the image.