2000 X-Ray - Tomographic
FDA 510(k) K931815 · Imaging Sciences Intl., Inc.
510(k) numberK931815
Submission
- Device name
- 2000 X-Ray - Tomographic
- Applicant
- Imaging Sciences Intl., Inc.
Gwynedd, PA, US - Received
- April 8, 1993
- Decision date
- August 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Ge Medical Systems, LLC
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| K061284 | I-Cat ScannerMUH · Traditional | 07/03/2006SE |
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| K041078 | Surgplan and PanplanLLZ · Traditional | 12/23/2004SE |
| K001248 | Multi-Pulse 2000EHD · Traditional | 05/04/2000SE |
| K991518 | PanatomeEHD · Traditional | 06/18/1999SE |
| K981466 | XR-910IZL · Traditional | 07/14/1998SE |
Questions and answers
When was 2000 X-Ray - Tomographic cleared by the FDA?
2000 X-Ray - Tomographic (K931815) received a 510(k) decision of Substantially Equivalent on August 23, 1993, 137 days after the submission was received.
What is the product code of K931815?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.