(135 days)
Not Found
No
The document describes a plan and image management application for radiation therapy, focusing on data storage, access, modification, and verification tools. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML-powered devices.
No
The device is a software application for managing and planning radiation therapy, not a device that directly delivers treatment or has a therapeutic effect on the patient. It assists staff in preparing and verifying treatments.
No
The device is described as a "plan and image management application" for radiation therapy, focusing on preparing and approving treatment plans, performing quality assurance, and managing treatment histories. While it handles "image data from diagnostic studies," its primary function is not to perform diagnosis itself, but to manage and process data for treatment purposes.
Yes
The device is described as a "treatment plan and image management application" and its functions are entirely software-based (entering, accessing, modifying, storing, archiving data, storing histories, providing verification tools). There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for managing and processing medical images and treatment plans for radiation therapy. It focuses on assisting radiation therapy staff in preparing, approving, and verifying treatments. This is a clinical application, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description reinforces the focus on treatment plan and image management within a radiation therapy context.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that scope.
N/A
Intended Use / Indications for Use
Vision is a plan and image management application that is intended to enable an authorized user to enter, access, modify, store and archive plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ, 90 IYE, 90 KPQ
Device Description
The name Varis Images has changed to Vision. The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive plan and image data from diagnositic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiation therapy staff
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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KOH2954
MAR 1 1 2005
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the Trilogy Radiotherapy Delivery System
l. Submitter:
ﺳﮯ
Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran(@)varian.com Date summary was prepared: October 25, 2004
2. Name of the Device:
Vision Trade/Proprietary Name: Image Database Common or Usual Name: Radiological Image Processing System Classification Name: 21 CFR §892.5840 Class II Product Code: 90 LLZ
3. Predicate Devices:
4. Description of the Device:
The name Varis Images has changed to Vision. The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive plan and image data from diagnositic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
5. Intended Use Statement:
Vision is a plan and image management application that is intended to enable an authorized user to enter, access, modify, store and archive plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
- Summary of the Technological Characteristics: The Substantial Equivalence 6. Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
MAR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc, 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K042956 Trade/Device Name: Vision™ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Product Code: 90 IYE Regulation Number: 21 CFR §892.5840 Regulation Name: Radiation therapy stimulation system Product Code: 90 KPQ Regulatory Class: II Dated: February 1, 2005 Received: February 3, 2005
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your betermined 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 the enclosure) to regally manufact of the Medical Device Amendments, or to devices that have been May 20, 1710, the classified in accordans 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 do not require approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 (Premarket n your device is elassince (to such additional controls. Existing major regulations affecting your Apploval), It the 70 000 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that r case or action that be a cremination that your device complies with other requirements of the Act or any For has mass and regulations administered by other Federal agencies. You must comply with all the I cacal statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling ACL's requirements, morating but not as a set forth in the quality systems (QS) (21 CFR Part 80 73 god 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket notification. THE FDA midnig of Subscannal or 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 If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entired, "Thisotanany on your responsibilities under the Act from the 807.97). Tou may obtain other gollerer missional and Consumer Assistance at its toll-free number (800) DIVISIon of 311an Manufactures, Internet address http://www.fda.gov/cdrl/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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042957 510(k) Number (if known): Device Name: Vision
Indications For Use:
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
David A. Lyon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________