Vision Rt Inc
LONDON London, City of, GB
VISION RT INC appears in FDA device records in LONDON London, City of, GB. FDA records list 11 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Vision Rt Inc between 2006 and 2026. The busiest year on record is 2021, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2013 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253012 | AlignRT Plus (8.0) | IYE | Substantially Equivalent | |
| K243301 | MapRT | IYE | Substantially Equivalent | |
| K233622 | AlignRT Plus | IYE | Substantially Equivalent | |
| K231185 | MapRT | IYE | Substantially Equivalent | |
| K212583 | AlignRT Plus | IYE | Substantially Equivalent | |
| K203387 | AlignRT Plus | IYE | Substantially Equivalent | |
| K193431 | AlignRT Plus | IYE | Substantially Equivalent | |
| K181218 | AlignRT Plus | IYE | Substantially Equivalent | |
| K123371 | ALIGNRT PLUS | IYE | Substantially Equivalent | |
| K072171 | GATECT-RT | IYE | Substantially Equivalent | |
| K052682 | ALIGNRT | IYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017888782 | 3017888782 | VISION RT INC | 580 Howard Avenue, East Millstone, NJ 08873 US | 2026 | No device listings on this registration |
| 3004832819 | 3004832819 | VISION RT LIMITED | Dove House, LONDON London, City of N3 2JU GB | 2026 | |
| 3014428919 | 3014428919 | Vision RT Ltd | Jays Close, Basingstoke Hampshire RG22 4BS GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0998-2026 | The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. | Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56). | Class II | Open, Classified | |
| Z-0065-2019 | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172 | RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB | Class II | Terminated | |
| Z-2668-2016 | TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients. | Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases. | Class II | Terminated | |
| Z-2667-2016 | AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. | Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases. | Class II | Terminated | |
| Z-0934-2015 | AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. | Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened. | Class II | Terminated | |
| Z-0464-2015 | AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. | Potential failure of AlignRT to assert interlock. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain