Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
FDA 510(k) K173273 · Imaging Dynamics Company , Ltd.
510(k) numberK173273
Submission
- Device name
- Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
- Applicant
- Imaging Dynamics Company , Ltd.
Calgary, CA - Received
- October 12, 2017
- Decision date
- November 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | Rayence Co., Ltd. | 07/31/2026SE |
| K260820 | Vivix-S 4386W (FXRD-4386WA)MQB · Special | Vieworks Co., Ltd. | 06/18/2026SE |
| K252996 | Universal 1417PIMQB · Abbreviated | Konica Minolta Healthcare Americas, Inc. | 06/12/2026SE |
| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
| K250665 | SKR 3000MQB · Traditional | Konica Minolta, Inc. | 06/17/2025SE |
| K243734 | Wireless/ Wired X-Ray Flat Panel DetectorsMQB · Special | Allengers Medical Systems Limited | 04/18/2025SE |
| K242770 | Expd 114; Expd 114G; Expd 114P; Expd 114PGMQB · Special | DRTECH Corporation | 03/20/2025SE |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…MQB · Special | DRTECH Corporation | 03/19/2025SE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
More from Iray Imaging Technology (Haining) Limited
| 510(k) | Device | Decision |
|---|---|---|
| K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TGMQB · Special | 10/12/2017SE |
| K171175 | Aquarius 8600 1417WCMQB · Special | 10/05/2017SE |
| K170202 | Aquarius 8600MQB · Special | 02/22/2017SE |
| K111098 | Innovaxion FP, Innovaxion FP 1600 Plus, MagellanMQB · Special | 05/27/2011SE |
| K071401 | X3C 2200 Digital Radiographic SystemKPR · Special | 06/22/2007SE |
| K071408 | X3C 1100 Radiographic Table with Digital Radiographic DetectorKPR · Special | 06/13/2007SE |
| K071403 | X3C 1600 Digital Radiographic SystemKPR · Special | 06/11/2007SE |
| K071409 | X3C 1590 Digital Radiographic SystemKPR · Special | 06/08/2007SE |
| K071402 | X3C 1600 Plus Digital Radiographic SystemKPR · Special | 06/08/2007SE |
| K070079 | X3C Digital Radiographic DetectorMQB · Special | 01/31/2007SE |
Questions and answers
When was Aquarius 8600 1417WCI; Aquarius 8600 1717WCI cleared by the FDA?
Aquarius 8600 1417WCI; Aquarius 8600 1717WCI (K173273) received a 510(k) decision of Substantially Equivalent on November 9, 2017, 28 days after the submission was received.
What is the product code of K173273?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.