Aquarius 8600
by Imaging Dynamics Company Ltd
510(k) K170202
Aquarius 8600 is a medical device (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by Imaging Dynamics Company Ltd, cleared under FDA 510(k) K170202 on 22 Feb 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170202 | Date22 Feb 2017 | StatusActive |
Official records
- FDA 510(k) database K170202
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- FDA applicant
- Imaging Dynamics Company , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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