Phantom
FDA 510(k) K941363 · Dynarad Corp.
510(k) numberK941363
Submission
- Device name
- Phantom
- Applicant
- Dynarad Corp.
Deer Park, NY, US - Received
- March 21, 1994
- Decision date
- July 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K932356 | Nova XM2IZH · Traditional | 02/08/1995SE |
| K932353 | HF-110AIZL · Traditional | 01/31/1994SE |
| K932355 | 9150A, 1100FIZL · Traditional | 08/03/1993SE |
| K932354 | 9170, 1170IZL · Traditional | 07/23/1993SE |
| K931725 | Alpha IIEHD · Traditional | 07/14/1993SE |
Questions and answers
When was Phantom cleared by the FDA?
Phantom (K941363) received a 510(k) decision of Substantially Equivalent on July 20, 1994, 121 days after the submission was received.
What is the product code of K941363?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.