Advantx 1824 Spotfilm Device
FDA 510(k) K950317 · GE Medical Systems
510(k) numberK950317
Submission
- Device name
- Advantx 1824 Spotfilm Device
- Applicant
- GE Medical Systems
Waukesha, WI, US - Received
- January 26, 1995
- Decision date
- February 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K940386 | Kodak Automixer III Integrated, Kodak Automixer III 180 LPIXL · Traditional | Eastman Kodak Company | 08/17/1994SE |
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| 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 Advantx 1824 Spotfilm Device cleared by the FDA?
Advantx 1824 Spotfilm Device (K950317) received a 510(k) decision of Substantially Equivalent on February 8, 1995, 13 days after the submission was received.
What is the product code of K950317?
The FDA product code is IXL – Device, Spot-Film, a Class II (moderate risk) device regulated under 21 CFR 892.1670.