JAC — System, X-Ray, Film Marking, Radiographic Class I
FDA product code JAC covers "System, X-Ray, Film Marking, Radiographic", a Class I medical device regulated under 21 CFR 892.1640. Submissions are reviewed by the Radiology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JAC
- Device Class
- Class I
- Regulation Number
- 892.1640
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K942883 | miles inc., agfa division | DIGITAL I.D. CAMERA | September 30, 1994 |
| K930752 | i.z.i | CT/MRI TOPOGRAPHIC MARKER | November 19, 1993 |
| K932357 | fujifilm medical system u.s.a | FUJI EC ID CAMERA | July 26, 1993 |
| K925892 | solstice | SOLSTICE XRAY RING MARKER PAD | May 18, 1993 |
| K926404 | eastman kodak | KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L | March 4, 1993 |
| K923533 | planmeca usa | ADMARK | March 4, 1993 |
| K924345 | fischer imaging | RADIOGRAPHIC FILM MARKETING SYSTEM | November 27, 1992 |
| K925332 | bennett x-ray technologies | BENNETT X-RAY ID PLUS | November 27, 1992 |
| K920031 | eastman kodak | KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE | February 12, 1992 |
| K915088 | eastman kodak | KODAK MIN-R IDENTIFICATION CAMERA | December 2, 1991 |
| K913478 | lorad medical systems | RADIOGRAPHIC FILM MARKING SYSTEM | October 15, 1991 |
| K911873 | macbrud corp. medical div | X-MARX | July 19, 1991 |
| K910354 | dupont medical products | DU PONT IDENTIFICATION CAMERA | March 29, 1991 |
| K890467 | eastman kodak | KODAK PORTABLE IDENTIFICATION CAMERA | February 16, 1989 |
| K882519 | karlin technology | X-RAY MARKER | August 9, 1988 |
| K870701 | eastman kodak | KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL | February 26, 1987 |
| K870565 | eastman kodak | KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L | February 26, 1987 |
| K852160 | truett laboratories | RADIOLOGICAL MARKING PEN | July 18, 1985 |