(118 days)
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No
The description focuses on standard computer hardware and software for radiation treatment planning, with no mention of AI or ML terms or capabilities.
No.
The "LINAC Scapel Treatment Planning System" is described as a software system aiding in the planning of radiation treatment, not directly administering therapy.
No
Explanation: The device is a 'Treatment Planning System' and is intended to aid in planning radiation treatment, not to diagnose medical conditions.
No
The device description explicitly states it is composed of hardware components (UNIX graphics computer, printer, digitizing graphics tablet) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in planning radiation treatment for lesions within the body. This is a therapeutic planning tool, not a diagnostic test performed on samples taken from the body.
- Device Description: The components (computer, printer, tablet, software) are consistent with a treatment planning system, not an in vitro diagnostic device which typically involves reagents, analyzers, or other components for testing biological samples.
- 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 laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to plan a medical treatment based on imaging and other patient data, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The LINAC Scapel Treatment Planning System is intended as a aid in quickly and precisely planning the radiation treatment of small lesions such as arteriovenous malformations, pituitary tumors. pincalomas, acoustic neuromas and malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The LINAC Scalpel Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer a digitizing graphics tablet, and radiation treatment planning application software.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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).
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§ 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
F 510(k) Summary
F.1 Company
NOV 12 1996 K962792
Surgical Navigation Technologies, Inc. 530 Compton B. onnfield. CO 80020 USA
Product Name F.2
LINAC Scalpel Treatment Planning System
F.3 Description
The LINAC Scalpel Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer a digitizing graphics tablet, and radiation treatment planning application software.
Intended Use and Indications F.4
The LINAC Scapel Treatment Planning System is intended as a aid in quickly and precisely planning the radiation treatment of small lesions such as arteriovenous malformations, pituitary tumors. pincalomas, acoustic neuromas and malignant neoplasms.
Substantial Equivalence F.5
The LINAC Scapel Treatment Planning System was clained to be substantially cquivalent to commercially available Radiation Treatment Planning Systems Information pertaining to these systems was provided in the submission.