Ultra Compact Video Imager
FDA 510(k) K930765 · International Imaging Electronics
510(k) numberK930765
Submission
- Device name
- Ultra Compact Video Imager
- Applicant
- International Imaging Electronics
Bolingbrook, IL, US - Received
- February 12, 1993
- Decision date
- September 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Siemens Medical Solutions USA, Inc.
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| K972019 | Pefect ShotEIA · Traditional | 07/03/1997SE |
| K970964 | Maestro Digital Image and Patient Record Storage SystemLLZ · Traditional | 06/13/1997SE |
| K953165 | Ultra Compact Video ImagerLMC · Traditional | 05/07/1996SE |
| K950330 | Digital Image Acquisition SystemIYO · Traditional | 05/07/1996SE |
| K940332 | Model Forty Ultra Compact Video ImagerLMC · Traditional | 06/08/1994SE |
| K934908 | Full View Digital Storage SystemIYO · Traditional | 01/28/1994SE |
| K930755 | Ultra Compact Video ImagerLMC · Traditional | 09/28/1993SE |
| K921992 | MP3000 Series III Video ImagerLMC · Traditional | 07/10/1992SE |
| K920373 | Maestro Digital Video SystemIYO · Traditional | 06/24/1992SE |
| K904897 | Model 400 Ultra Compact Video ImagerLMC · Traditional | 11/20/1990SE |
Questions and answers
When was Ultra Compact Video Imager cleared by the FDA?
Ultra Compact Video Imager (K930765) received a 510(k) decision of Substantially Equivalent on September 13, 1993, 213 days after the submission was received.
What is the product code of K930765?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.