(57 days)
K08128
Not Found
No
The description focuses on standard image viewing, comparison, and analysis tools for DICOM data, with no mention of AI or ML capabilities. The software is described as "principally a read-only activity" and produces no new data or modifications, which is inconsistent with typical AI/ML functions that often involve data generation or modification.
No
The device is described as a "review and evaluation" tool for existing patient data. It is "principally a read-only activity and produces no new data or modifications to the data". It displays and allows comparison of various medical images and data (e.g., RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET) but does not directly treat or diagnose.
No
The Oncentra RT Viewer is explicitly described as a tool for "review and evaluation of DICOM based patient data" and provides "read-only activity" that "produces no new data or modifications to the data". It helps specialists compile, compare, and manipulate existing views and images, as well as analyze and compare plans and doses, but it does not generate a medical diagnosis or interpret data to diagnose or monitor a condition itself.
Yes
The device description explicitly states "The software runs on a Windows XP or VISTA platform," and the entire description focuses on the software's functionalities for viewing and analyzing existing DICOM data. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, the Oncentra RT Viewer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Oncentra RT Viewer's intended use and description clearly state that it is used for reviewing and evaluating DICOM based patient data, which are medical images and related information, not biological specimens.
- The device's function is focused on displaying, comparing, and manipulating existing medical imaging data. It does not perform any tests or analyses on biological samples to provide diagnostic information about a patient's health status.
The Oncentra RT Viewer is a medical image viewing and analysis software used in the field of radiation therapy planning and evaluation. Its purpose is to assist qualified specialists in reviewing and understanding patient data for treatment purposes.
N/A
Intended Use / Indications for Use
The Oncentra RT Viewer is intended to be used for review and evaluation of DICOM based patient data by qualified specialists. It is used to load and display data generated by different DICOM modalities including, but not limited to: RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET.
It provides the user with a wide range of tools to compile, compare, and manipulate views and images. It enables super-positioning of geometrically related DICOM data.
Product codes
MUJ
Device Description
RT Viewer provides tools for analysis of single and summed plans, and for comparison of several alternative plans. All image series and all RT objects (Structure Set, Plans, RT Images and Dose) in the study can be displayed and explored.
RT Viewer is principally a read-only activity and produces no new data or modifications to the data for the study and the plan(s).
Single Plan Evaluation
- Display of plan dose in original, reconstructed planar and 3D images. .
- . Display of dose as a sequence of objects,
- ♥ Inspection and comparison of individual objects for a plan in a study.
- . Display of DVH in individual and total mode to view contributions from total plan or individual beams.
- Display of DVH statistics. .
Plan Comparison
- Side-by-side display of a plan for selected plans in a study, shown as a sequence of objects. .
- . Comparison of DVH and dose statistics for plans in a study.
Plan Summation
- Summation of dose distributions for plans and display of summed dose. ●
- Display of DVH in individual and total mode to view contributions from summed or ◆ individual plans.
The software runs on a Windows XP or VISTA platform.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified specialists
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)
K08128
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K0r2642
510(k) Nucletron Oncentra RT Viewer 1.0
tron
Page 29 July 2008
NOV - 7 2008 NUCLETRON B.V. Waardgelder 1 3905 THI Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)
Submitter of 510(k):
Company name: Registration number: Address:
Phone: Fax: Correspondent: Nucletron Corporation 1121753 8671 Robert Fulton Drive Columbia, MD 21046 410-312-4100 410-312-4197 Lisa Dimmick Director Assurance & Regulatory Affairs
New Device Name:
Trade/Proprietary Name: Oncentra RT Viewer 1.0. Common/Usual Name: Radiation Therapy Viewer System, Planning, Radiation Therapy Treatment Classification Name: Classification: 21Cfr892.5050 Class II
Legally Marketed Device(s)
Our new device is based on the legally marketed device cited in the table below:
| Manufacturer | Device
CALL CAL DECRECT SECTION COLLEGION TO SECTION OF THE SULL COLLEGION OF THE SULL | 510(k)
4 |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Nucletron BV | MasterPlan 3 | K08128 |
| a way age with a feature of the count of the count of the count of the contribute with | annones in experience anyments of the collection of the collection and first and any for any and | Comments of NY 1 UP P.A. F. angere turns of many and experience with the more of the first would be and |
1
510(k)
Nucletron Oncentra RT Viewer 1.0
Description:
RT Viewer provides tools for analysis of single and summed plans, and for comparison of several alternative plans. All image series and all RT objects (Structure Set, Plans, RT Images and Dose) in the study can be displayed and explored.
RT Viewer is principally a read-only activity and produces no new data or modifications to the data for the study and the plan(s).
Single Plan Evaluation
- Display of plan dose in original, reconstructed planar and 3D images. .
- . Display of dose as a sequence of objects,
- ♥ Inspection and comparison of individual objects for a plan in a study.
- . Display of DVH in individual and total mode to view contributions from total plan or individual beams.
- Display of DVH statistics. .
Plan Comparison
- Side-by-side display of a plan for selected plans in a study, shown as a sequence of objects. .
- . Comparison of DVH and dose statistics for plans in a study.
Plan Summation
- Summation of dose distributions for plans and display of summed dose. ●
- Display of DVH in individual and total mode to view contributions from summed or ◆ individual plans.
The software runs on a Windows XP or VISTA platform.
Intended use:
The Oncentra RT Viewer is intended to be used for review and evaluation of DICOM based patient data by qualified specialists. It is used to load and display data generated by different DICOM modalities including, but not limited to: RT Image, RT Structure Set, RT Plan, RT Dose, CT. CR. MR. and PET.
It provides the user with a wide range of tools to compile, compare, and manipulate views and images. It enables super-positioning of geometrically related DICOM data.
Summary of technological considerations:
Oncentra RT Viewer 1.0 is substantially equivalent to the cleared predicate device. The cleared predicate device, Oncentra MasterPlan 3.1, has a wide intended use than the new device Oncentra RT Viewer 1.0 which is merely a viewer.
ay
Name: Paul Van den Biggelaar Title: Director Oncentra Nucletron B.V. Veenendaal, The Netherlands
2009.02.08
Date
Page 5 July 2008
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Nucletron Corporation % Mr. Daniel W. Lehtonen Senior Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K082642
Trade/Device Name: Oncentra RT Viewer 1.0. Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 27, 2008 Received: October 28, 2008
Dear Mr. Lehtonen:
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.
3
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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jaque M. Zhang
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
4
510(k) Nucletron Oncentra RT Viewer 1.0
Page 31 July 2008
Indications for Use Statement
510(k) Number
Device Name
Indications for Use
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":
1 ...... -
ﻠ .
1.11
Oncentra RT Viewer 1.0.
The Oncentra RT Viewer is intended to be used for review and evaluation of DICOM based patient data by qualified specialists. It is used to load and display data generated by different DICOM modalities including, but not limited to: RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET.
It provides the user with a wide range of tools to compile, compare, and manipulate views and images. It enables super-positioning of geometrically related DICOM data.
Prescription Use __ X (Part 21 CFR 801 subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Julin Remen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _
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