Synepix 4600 Detector
FDA 510(k) K070829 · Analogic Corporation
510(k) numberK070829
Submission
- Device name
- Synepix 4600 Detector
- Applicant
- Analogic Corporation
Peabody, MA, US - Received
- March 26, 2007
- Decision date
- May 9, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| K161342 | Sonic WindowIYO · Special | 06/15/2016SE |
| K140126 | Sonic WindowIYO · Abbreviated | 03/04/2014SE |
| K071430 | Synerad Omni, Models AN6255 and AN6265KPR · Special | 06/21/2007SE |
| K051903 | Fetalgard Lite-Nibp, Model Fgl-NibpDXN · Traditional | 12/27/2005SE |
| K052447 | Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600JAK · Abbreviated | 09/21/2005SE |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…DSI · Abbreviated | 06/14/2005SE |
| K043025 | Synerad Omni, Digital X-Ray System, Model AN6250KPR · Abbreviated | 11/19/2004SE |
Questions and answers
When was Synepix 4600 Detector cleared by the FDA?
Synepix 4600 Detector (K070829) received a 510(k) decision of Substantially Equivalent on May 9, 2007, 44 days after the submission was received.
What is the product code of K070829?
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.