(86 days)
Not Found
Not Found
No
The summary explicitly states the device is an improvement of existing, previously cleared products and does not mention AI, ML, or related concepts.
Yes
Linear accelerators are devices used to deliver radiation therapy, which is a therapeutic treatment for conditions like cancer.
No
The device description indicates it is a linear accelerator and MLC product, which are therapeutic devices used for radiation treatment, not for diagnosing conditions.
No
The device description explicitly states it is an improvement of existing linear accelerators and MLC products, which are hardware devices used in radiation therapy. There is no mention of the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on linear accelerators and MLC products, which are used for external radiation therapy, not for testing samples of human origin outside the body.
- No mention of diagnostic purpose: The description doesn't indicate that the device is used to diagnose diseases or conditions.
- Focus on treatment delivery: Linear accelerators and MLCs are components of radiation therapy systems used for treating patients.
The information provided strongly suggests this is a therapeutic device used in radiation oncology, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The SLi Series Linear Accelerators and MLCi products are improvements of the existing SL Series and the Philips MLC products which have previously been cleared for commercial distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
| | | Dec. 6, 1996 R963624
Philips Medical Systems - Radiotherapy, hereby provide the following
material summarising safety and effectiveness information for the Philips
SLi Series Linear Accelerators and MLCi products. This information is
summarised as follows:- | |
|--|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| | 1) | The SLi Series Linear Accelerators and MLCi products are
improvements of the existing SL Series and the Philips MLC
products which have previously been cleared for commercial
distribution. These devices have an established and proven
track record for safety. The SLi Series Linear Accelerators and
MLCi products do not raise additional types of safety or
effectiveness considerations when compared against the existing
functions provided by the Philips SL Series fitted with MLC. | |
| | 2) | The accompanying documents provided for the user contain
comprehensive information to ensure safe and effective use.
Past experience with substantially equivalent predicate devices
has shown our device to be safe and effective when used as
directed by the accompanying documents provided for the user. | |
| | 3) | It is our opinion that the Philips SLi Series Linear
Accelerators and MLCi products do not have technological
characteristics that raise additional types of safety or '
effectiveness questions, and that we consider them an
enhancement to the existing SL Series Linear Accelerators and
MLC products. | |
| | 4) | The SLi Series Linear Accelerators and MLCi products have been
subject to compliance testing as defined in the internationally
recognised safety standards IEC 601-1 and IEC 601-2-1. As
appropriate, proprietary information technology equipment is
procured to the internationally recognised standards IEC 950
and/or UL 1950. | |
| | 5) | All products bear the CE mark affirming compliance with all
relevant European Directives in force. In particular compliance
has been assured to the European Medical Device Directive and
the European Electromagnetic Compatibility Directive.
Additionally the total system is subject to the provision of
the Code of Federal Regulations, Title 21: Food and Drugs. | |
| | 6) | The SLi Series Linear Accelerators and MLCi products have been
designed to ensure that compliance to the above standards is
maintained. | |
| | REF: 804/
PC52MA06926
QA6M0100 | SUMMARY OF SAFETY AND EFFECTIVENESS
INFORMATION FOR THE PHILIPS
SLi SERIES LINEAR ACCELERATORS | N.C. 4513 364 1752
Attachment No: 26
Sht. 1 29.08.96 |
1
PMS-R is a Department of Health GMP registered medical device manufacturer of assessed capability, against the requirements of ISO 9001, EN 46001, and the UK Department of Health GMP This Software Quality System has been established to satisfy the requirements of ISO 9001, EN 46001, the UK Department of Health GMP and the US 21 CFR 820 GMP. Philips Medical Systems Radiotherapy has developed the SLi Series Linear Accelerators and the MLCi products using an established and documented Software Quality Management System.
In accordance with the above requirements all parts of the Quality System are subject to periodic and systematic internal Quality Audits. These audits are performed by trained personnel not having direct responsibilities in the functions being audited.
- g) Additionally the quality system is subject to regular, planned and documented GMP audits conducted by external auditors from the UK Department of Health, SGS Yarsley and the FDA.
-
- PMS-R has conducted hazard analysis on the Philips SLi Series Linear Accelerators and the MLCi products and have concluded that it introduces no new hazards and that the level of concern appropriate to the SLi Series Linear Accelerators and the MLCi products is moderate.
Signature
Signature
Signature
Hart
Development Director
Development Director
le
Company Marketing Manager
C. Everett
Assurance Manager
SUMMARY OF SAFETY AND EFFECTIVENESS RFF : 8041 N.C. 4513 364 1/52 INFORMATION FOR THE PHILIF 26 Attachment No: SLi SERIES LINEAR ACCELERATOR QA6M0100 Sht 29.08.96
PHILIPS MEDICAL SYSTEMS - RADIOTHERAPY
I THE COPYRIGHT OF THIS DOCUSED FOR BE I
SUPPLIED AND MUSE MOT BE USED FOR BE I
SUPPLIED AND MUSE MOT MUSE BE I
LIPS MEDICAL SYSTEMS - RADIOTHER
PHILIPS MEDICAL SYSTEMS - RADI
DIVISION OF PHILIPS ELECTRONICS UK LIMITED