Kodak Directview DR System Detector
FDA 510(k) K051483 · Eastman Kodak Company
510(k) numberK051483
Submission
- Device name
- Kodak Directview DR System Detector
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- June 6, 2005
- Decision date
- June 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MQB
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| 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 |
|---|---|---|
| K060550 | Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386KPR · Special | 03/31/2006SE |
| K060137 | Kodak Eclipse Image Processing SoftwareMQB · Special | 03/16/2006SE |
| K060079 | Kodak Model CR-7400 Digital Radiography SystemMUH · Special | 02/08/2006SE |
| K060055 | Kodak PacsLLZ · Traditional | 02/07/2006SE |
| K053347 | Kodak Carestream PacsLLZ · Special | 01/04/2006SE |
| K051258 | Kodak Directview DR 7500 System, Model 8791345KPR · Special | 06/01/2005SE |
| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | 09/24/2004SE |
| K040378 | Kodak Directview CR CASSETTE/GP/15 X 30 CM, Catalog# 8418253IXA · Traditional | 05/24/2004SE |
| K040556 | Trophypan C with Orthoimaging/Omsimaging AccessoryEHD · Special | 04/07/2004SE |
Questions and answers
When was Kodak Directview DR System Detector cleared by the FDA?
Kodak Directview DR System Detector (K051483) received a 510(k) decision of Substantially Equivalent on June 21, 2005, 15 days after the submission was received.
What is the product code of K051483?
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.