AX200 Automatic X-Ray Film Processor, Model 6586.036
FDA 510(k) K023613 · Alphatek Corp.
510(k) numberK023613
Submission
- Device name
- AX200 Automatic X-Ray Film Processor, Model 6586.036
- Applicant
- Alphatek Corp.
Broadview, IL, US - Received
- October 28, 2002
- Decision date
- January 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K022154 | Level 356 X-Ray Film Processor, Models MD & Md-DIXW · Traditional | Fischer Industries, Inc. | 09/30/2002SE |
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| K002404 | Micro-Max, Model 319IXW · Traditional | Tek Marketing, Inc. | 08/30/2000SE |
| K001321 | All-Pro 2010IXW · Traditional | All-Pro Imaging Corp. | 05/16/2000SE |
More from All-Pro Imaging Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K931883 | AX-390SE Automatic X-Ray Film Processor 9586.033IXW · Traditional | 08/23/1993SE |
| K931882 | MAMMO-300 Automatic X-Ray Film ProcessorIXW · Traditional | 08/23/1993SE |
| K925569 | AX-700LE Automatic X-Ray Film ProcessorIXW · Traditional | 01/15/1993SE |
| K924430 | AX-300SE Automatic X-Ray Film Processor, 6586.027IXW · Traditional | 11/27/1992SE |
Questions and answers
When was AX200 Automatic X-Ray Film Processor, Model 6586.036 cleared by the FDA?
AX200 Automatic X-Ray Film Processor, Model 6586.036 (K023613) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 87 days after the submission was received.
What is the product code of K023613?
The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.