RIT 113 Film Analysis System
by Radiological Imaging Technology, Inc.
510(k) K935928
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935928 | Date29 Jul 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The RIT 113 Film Analysis System is a medical device classified as an Accelerator, Linear, Medical under FDA device classification. It is a film dosimetry quality assurance software system designed for use in radiological imaging and radiation therapy quality assurance.
The system is supplied as a software solution for medical physicists and is used in clinical settings for analyzing film dosimetry data, including IMRT, VMAT, machine QA, and EBT3/EBT4 flatbed scanner correction. It received FDA 510(k) clearance (K935928) on July 29, 1994, and is classified as a Class II device under regulation number 892.5050.
From the manufacturer
Advanced QA Software Solutions For over 30 years, Radiological Imaging Technology ® has provided medical physicists with an all-encompassing range of industry-leading QA software solutions, specifically engineered to ensure proper compliance with established protocols within the fields of therapeutic and diagnostic physics.
RIT Film is a full suite of film dosimetry QA routines, which includes IMRT analysis, VMAT analysis, Machine QA, and EBT3 / EBT4 Flatbed Scanner Correction.
Manufacturer's product page: RIT Film