Gatect-Rt
FDA 510(k) K072171 · Vision RT Limited
510(k) numberK072171
Submission
- Device name
- Gatect-Rt
- Applicant
- Vision RT Limited
Lincoln, CA, US - Received
- August 6, 2007
- Decision date
- October 1, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K212583 | AlignRT PlusIYE · Traditional | 11/10/2021SE |
| K203387 | AlignRT PlusIYE · Traditional | 03/04/2021SE |
| K193431 | AlignRT PlusIYE · Special | 01/03/2020SE |
| K181218 | AlignRT PlusIYE · Traditional | 08/07/2018SE |
| K123371 | Alignrt PlusIYE · Traditional | 01/08/2013SE |
| K052682 | AlignrtIYE · Traditional | 01/06/2006SE |
Questions and answers
When was Gatect-Rt cleared by the FDA?
Gatect-Rt (K072171) received a 510(k) decision of Substantially Equivalent on October 1, 2007, 56 days after the submission was received.
What is the product code of K072171?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.