Radiographic Film Marking System
FDA 510(k) K913478 · Lorad Medical Systems, Inc.
510(k) numberK913478
Submission
- Device name
- Radiographic Film Marking System
- Applicant
- Lorad Medical Systems, Inc.
Danbury, CT, US - Received
- August 6, 1991
- Decision date
- October 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K942883 | Digital I.D. CameraJAC · Traditional | Miles Inc., Agfa Division | 09/30/1994SE |
| 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 |
| K924345 | Radiographic Film Marketing SystemJAC · Traditional | Fischer Imaging Corp. | 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 |
More from Eastman Kodak Company
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| K913732 | Mammographic X-Ray SystemIZH · Traditional | 02/03/1992SE |
| K894935 | S-70 Portable Dental X-Ray SystemEHD · Traditional | 04/25/1990SE |
| K894643 | RT-125 Rough Terrain Mobile X-Ray UnitIZL · Traditional | 12/14/1989SE |
| K882875 | Stereotactic Breast Lesion Localization AccessoryIZH · Traditional | 11/07/1988SE |
| K842102 | LoradIZH · Traditional | 07/17/1984SE |
Questions and answers
When was Radiographic Film Marking System cleared by the FDA?
Radiographic Film Marking System (K913478) received a 510(k) decision of Substantially Equivalent on October 15, 1991, 70 days after the submission was received.
What is the product code of K913478?
The FDA product code is JAC – System, X-Ray, Film Marking, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1640.