JAC · System, X-Ray, Film Marking, Radiographic
Radiology · 21 CFR 892.1640 · Class 1
Overview
| Product Code | JAC |
|---|---|
| Device Name | System, X-Ray, Film Marking, Radiographic |
| Regulation | 21 CFR 892.1640 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942883 | DIGITAL I.D. CAMERA | Miles Inc., Agfa Division | Sep 30, 1994 | SESE |
| K930752 | CT/MRI TOPOGRAPHIC MARKER | I.Z.I. Corp. | Nov 19, 1993 | SESE |
| K932357 | FUJI EC ID CAMERA | Fujifilm Medical System U.S.A., Inc. | Jul 26, 1993 | SESE |
| K925892 | SOLSTICE XRAY RING MARKER PAD | Solstice Corp. | May 18, 1993 | SESE |
| K926404 | KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L | Eastman Kodak Company | Mar 4, 1993 | SESE |
| K923533 | ADMARK | Planmeca USA, Inc. | Mar 4, 1993 | SESE |
| K925332 | BENNETT X-RAY ID PLUS | Bennett X-Ray Technologies | Nov 27, 1992 | SESE |
| K924345 | RADIOGRAPHIC FILM MARKETING SYSTEM | Fischer Imaging Corp. | Nov 27, 1992 | SESE |
| K920031 | KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE | Eastman Kodak Company | Feb 12, 1992 | SESE |
| K915088 | KODAK MIN-R IDENTIFICATION CAMERA | Eastman Kodak Company | Dec 2, 1991 | SESE |
| K913478 | RADIOGRAPHIC FILM MARKING SYSTEM | Lorad Medical Systems, Inc. | Oct 15, 1991 | SESE |
| K911873 | X-MARX | Macbrud Corp. Medical Div. | Jul 19, 1991 | SESE |
| K910354 | DU PONT IDENTIFICATION CAMERA | Dupont Medical Products | Mar 29, 1991 | SESE |
| K890467 | KODAK PORTABLE IDENTIFICATION CAMERA | Eastman Kodak Company | Feb 16, 1989 | SESE |
| K882519 | X-RAY MARKER | Karlin Technology, Inc. | Aug 9, 1988 | SESE |
| K870701 | KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL | Eastman Kodak Company | Feb 26, 1987 | SESE |
| K870565 | KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L | Eastman Kodak Company | Feb 26, 1987 | SESE |
| K852160 | RADIOLOGICAL MARKING PEN | Truett Laboratories, Inc. | Jul 18, 1985 | SESE |
Top Applicants
- Eastman Kodak Company — 6 clearances
- Truett Laboratories, Inc. — 1 clearance
- Solstice Corp. — 1 clearance
- Planmeca USA, Inc. — 1 clearance
- Miles Inc., Agfa Division — 1 clearance
