Veridose Diodes
FDA 510(k) K964785 · Victoreen, Inc.
510(k) numberK964785
Submission
- Device name
- Veridose Diodes
- Applicant
- Victoreen, Inc.
Solon, OH, US - Received
- November 29, 1996
- Decision date
- June 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K964952 | Veridose V (Five), Model Number 37-705JAD · Traditional | 07/21/1997SE |
| K971382 | Prone Breast Positioning Board, Model #37-018IYE · Traditional | 06/06/1997SE |
| K952233 | Clear-Pb Lead Plastic Overhead Barrier 56-628EAK · Traditional | 06/16/1995SE |
| K940660 | Model 37-720 Dual Diode Dosimetry SystemIYE · Traditional | 12/09/1994SE |
| K935435 | Nuclear Assoc 37-08 Ser, Raycast HP Radio Immob SystIYE · Traditional | 07/29/1994SE |
| K941931 | Diagnostic X-Ray Patient Exposure IndicatorKPR · Traditional | 05/26/1994SE |
| K934549 | All-Vue Ultra-Lite Thin Wall Syringe ShieldIWR · Traditional | 02/19/1994SE |
Questions and answers
When was Veridose Diodes cleared by the FDA?
Veridose Diodes (K964785) received a 510(k) decision of Substantially Equivalent on June 13, 1997, 196 days after the submission was received.
What is the product code of K964785?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.