Axt 1400 Spotfilm Device
FDA 510(k) K942367 · Applied X-Ray Technologies, Inc.
510(k) numberK942367
Submission
- Device name
- Axt 1400 Spotfilm Device
- Applicant
- Applied X-Ray Technologies, Inc.
Denver, CO, US - Received
- May 18, 1994
- Decision date
- June 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111304 | Optima XR120IXL · Special | Ge Medical Systems, LLC | 07/19/2011SE |
| K964806 | MD-1835IXL · Traditional | Fischer Imaging Corp. | 03/04/1997SE |
| K950317 | Advantx 1824 Spotfilm DeviceIXL · Traditional | GE Medical Systems | 02/08/1995SE |
| K940386 | Kodak Automixer III Integrated, Kodak Automixer III 180 LPIXL · Traditional | Eastman Kodak Company | 08/17/1994SE |
| K924593 | Diagnost 76 Family*R/F Systems - Release 4.4IXL · Traditional | Philips Medical Systems, Inc. | 11/24/1992SE |
| K902403 | Elite R/F Spot Film DriveIXL · Traditional | Rms Div. | 08/01/1990SE |
| K902146 | SFD-035 Spot Film DeviceIXL · Traditional | Rms Div. | 05/31/1990SE |
| K882492 | A.X.T. Spotfilm DeviceIXL · Traditional | Applied X-Ray Technologies, Inc. | 07/21/1988SE |
| K881589 | 14X14 Multiformat Spot Filmer, No. 6650.400IXL · Traditional | Continental X-Ray Corp. | 07/18/1988SE |
| K842184 | Spot-Film Device 8835IXL · Traditional | General Electric Co. | 07/17/1984SE |
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Questions and answers
When was Axt 1400 Spotfilm Device cleared by the FDA?
Axt 1400 Spotfilm Device (K942367) received a 510(k) decision of Substantially Equivalent on June 6, 1994, 19 days after the submission was received.
What is the product code of K942367?
The FDA product code is IXL – Device, Spot-Film, a Class II (moderate risk) device regulated under 21 CFR 892.1670.