JACClass I

System, X-Ray, Film Marking, Radiographic

21 CFR 892.1640 / Radiology

JAC is the FDA product code for System, X-Ray, Film Marking, Radiographic, a class I device type, regulated under 21 CFR 892.1640. As of 2026-09-10, FDA records hold 18 510(k) clearances under this code, the most recent dated 1994-09-30, and 15 recalls.

Classification record

Product code: JAC
Device name: System, X-Ray, Film Marking, Radiographic
Regulation: 21 CFR 892.1640
Device class: Class I
Review panel: Radiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 18
Ingested recalls: 15

Clearances, product code JAC

By decision year

18 clearances under product code JAC with a decision year between 1985 and 1994, 1993 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code JAC by decision year
Year	Clearances
1985	1
1987	2
1988	1
1989	1
1991	4
1992	3
1993	5
1994	1

Applicants with the most clearances

Product code JAC

Applicants holding the most 510(k) clearances under product code JAC
Applicant	Clearances
Eastman Kodak Company	6
Bennett X-Ray Technologies	1
Dupont Medical Products	1
Fischer Imaging Corp.	1
FUJIFILM Healthcare Americas Corporation	1
I.Z.I. Corp.	1
Karlin Technology, Inc.	1
Lorad Medical Systems, Inc.	1
Macbrud Corp. Medical Div.	1
Miles Inc., Agfa Division	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order