System, X-Ray, Film Marking, Radiographic
A radiographic film marking system is used to annotate radiographic images with patient identification, laterality markers, or other information directly onto the film during exposure, ensuring accurate identification and orientation of diagnostic images. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is JAC, regulated under 21 CFR 892.1640, within the Radiology medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- JAC
- Device Class
- FDA class 1
- Regulation Number
- 892.1640
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942883 | DIGITAL I.D. CAMERA | Sep 30, 1994 | Substantially Equivalent | Miles Inc., Agfa Division |
| K930752 | CT/MRI TOPOGRAPHIC MARKER | Nov 19, 1993 | Substantially Equivalent | I.Z.I. Corp. |
| K932357 | FUJI EC ID CAMERA | Jul 26, 1993 | Substantially Equivalent | Fujifilm Medical System U.S.A., Inc. |
| K925892 | SOLSTICE XRAY RING MARKER PAD | May 18, 1993 | Substantially Equivalent | Solstice Corp. |
| K926404 | KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L | Mar 04, 1993 | Substantially Equivalent | Eastman Kodak Company |
| K923533 | ADMARK | Mar 04, 1993 | Substantially Equivalent | Planmeca USA, Inc. |
| K925332 | BENNETT X-RAY ID PLUS | Nov 27, 1992 | Substantially Equivalent | Bennett X-Ray Technologies |
| K924345 | RADIOGRAPHIC FILM MARKETING SYSTEM | Nov 27, 1992 | Substantially Equivalent | Fischer Imaging Corp. |
| K920031 | KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE | Feb 12, 1992 | Substantially Equivalent | Eastman Kodak Company |
| K915088 | KODAK MIN-R IDENTIFICATION CAMERA | Dec 02, 1991 | Substantially Equivalent | Eastman Kodak Company |
| K913478 | RADIOGRAPHIC FILM MARKING SYSTEM | Oct 15, 1991 | Substantially Equivalent | Lorad Medical Systems, Inc. |
| K911873 | X-MARX | Jul 19, 1991 | Substantially Equivalent | Macbrud Corp. Medical Div. |
| K910354 | DU PONT IDENTIFICATION CAMERA | Mar 29, 1991 | Substantially Equivalent | Dupont Medical Products |
| K890467 | KODAK PORTABLE IDENTIFICATION CAMERA | Feb 16, 1989 | Substantially Equivalent | Eastman Kodak Company |
| K882519 | X-RAY MARKER | Aug 09, 1988 | Substantially Equivalent | Karlin Technology, Inc. |
| K870701 | KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL | Feb 26, 1987 | Substantially Equivalent | Eastman Kodak Company |
| K870565 | KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L | Feb 26, 1987 | Substantially Equivalent | Eastman Kodak Company |
| K852160 | RADIOLOGICAL MARKING PEN | Jul 18, 1985 | Substantially Equivalent | Truett Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.