Radiographic Film Marketing System
FDA 510(k) K924345 · Fischer Imaging Corp.
510(k) numberK924345
Submission
- Device name
- Radiographic Film Marketing System
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- August 27, 1992
- Decision date
- November 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K930752 | Ct/Mri Topographic MarkerJAC · Traditional | I.Z.I. Corp. | 11/19/1993SE |
| K932357 | Fuji Ec Id CameraJAC · Traditional | Fujifilm Medical System U.S.A., Inc. | 07/26/1993SE |
| K925892 | Solstice Xray Ring Marker PadJAC · Traditional | Solstice Corp. | 05/18/1993SE |
| K926404 | Kodak X-Omatic Identification Camera, Model 4 & 4LJAC · Traditional | Eastman Kodak Company | 03/04/1993SE |
| K923533 | AdmarkJAC · Traditional | Planmeca USA, Inc. | 03/04/1993SE |
| K925332 | Bennett X-Ray Id PlusJAC · Traditional | Bennett X-Ray Technologies | 11/27/1992SE |
| K920031 | Kodak X-Omatic Ident. Camera Mammography UpgradeJAC · Traditional | Eastman Kodak Company | 02/12/1992SE |
| K915088 | Kodak Min-R Identification CameraJAC · Traditional | Eastman Kodak Company | 12/02/1991SE |
| K913478 | Radiographic Film Marking SystemJAC · Traditional | Lorad Medical Systems, Inc. | 10/15/1991SE |
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Questions and answers
When was Radiographic Film Marketing System cleared by the FDA?
Radiographic Film Marketing System (K924345) received a 510(k) decision of Substantially Equivalent on November 27, 1992, 92 days after the submission was received.
What is the product code of K924345?
The FDA product code is JAC – System, X-Ray, Film Marking, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1640.