The following data is part of a premarket notification filed by Imaging Dynamics Company Ltd. with the FDA for Aquarius 8600 1417wc.
| Device ID | K171175 |
| 510k Number | K171175 |
| Device Name: | Aquarius 8600 1417WC |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Imaging Dynamics Company Ltd. #130, 5310-29th Street NE Calgary, CA T1y 7e5 |
| Contact | Nicole Wherry |
| Correspondent | Nicole Wherry Imaging Dynamics Company Ltd. #130, 5310-29th Street NE Calgary, CA T1y 7e5 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-21 |
| Decision Date | 2017-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00823073003217 | K171175 | 000 |