9170, 1170
FDA 510(k) K932354 · Dynarad Corp.
510(k) numberK932354
Submission
- Device name
- 9170, 1170
- Applicant
- Dynarad Corp.
Deer Park, NY, US - Received
- May 13, 1993
- Decision date
- July 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from H&abyz Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K000052 | X-Ray Monoblock, Monoblock XRS-60-330ITY · Traditional | 02/10/2000SE |
| K981267 | Facts MonoblockIZX · Traditional | 05/06/1998SE |
| K973833 | Control, X-Ray Diagnostic, Generator, High Voltage, Assembly, Tube Housing Diagnostic…IZL · Traditional | 12/30/1997SE |
| K932356 | Nova XM2IZH · Traditional | 02/08/1995SE |
| K941363 | PhantomIZL · Traditional | 07/20/1994SE |
| K932353 | HF-110AIZL · Traditional | 01/31/1994SE |
| K932355 | 9150A, 1100FIZL · Traditional | 08/03/1993SE |
| K931725 | Alpha IIEHD · Traditional | 07/14/1993SE |
Questions and answers
When was 9170, 1170 cleared by the FDA?
9170, 1170 (K932354) received a 510(k) decision of Substantially Equivalent on July 23, 1993, 71 days after the submission was received.
What is the product code of K932354?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.