Dx-D Imaging Package
FDA 510(k) K141602 · Agfa Healthcare N.V.
510(k) numberK141602
Submission
- Device name
- Dx-D Imaging Package
- Applicant
- Agfa Healthcare N.V.
Greenville, SC, US - Received
- June 16, 2014
- Decision date
- September 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K252199 | AGFA HealthCare Enterprise ImagingLLZ · Traditional | 10/15/2025SE |
| K180589 | DR 800 with MUSICA DynamicJAA · Traditional | 04/05/2018SE |
| K172784 | DX-D Imaging PackageMQB · Traditional | 10/13/2017SE |
| K170434 | Enterprise Imaging XERO Viewer 8.1LLZ · Traditional | 07/03/2017SE |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR…MQB · Traditional | 09/22/2016SE |
| K161061 | IMPAX Volume Viewing 4.0LLZ · Traditional | 06/22/2016SE |
| K152639 | DR 600MQB · Traditional | 12/11/2015SE |
| K143397 | ICIS ViewLLZ · Traditional | 06/01/2015SE |
| K142316 | IMPAX AgilityLLZ · Traditional | 01/06/2015SE |
| K142184 | Dx-D Imaging PackageMQB · Traditional | 10/16/2014SE |
Questions and answers
When was Dx-D Imaging Package cleared by the FDA?
Dx-D Imaging Package (K141602) received a 510(k) decision of Substantially Equivalent on September 12, 2014, 88 days after the submission was received.
What is the product code of K141602?
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.