Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1640](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1640) → JAC — System, X-Ray, Film Marking, Radiographic # JAC · System, X-Ray, Film Marking, Radiographic _Radiology · 21 CFR 892.1640 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC ## Overview - **Product Code:** JAC - **Device Name:** System, X-Ray, Film Marking, Radiographic - **Regulation:** [21 CFR 892.1640](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1640) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K942883.md) | DIGITAL I.D. CAMERA | Miles Inc., Agfa Division | Sep 30, 1994 | SESE | | [K930752](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K930752.md) | CT/MRI TOPOGRAPHIC MARKER | I.Z.I. Corp. | Nov 19, 1993 | SESE | | [K932357](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K932357.md) | FUJI EC ID CAMERA | Fujifilm Medical System U.S.A., Inc. | Jul 26, 1993 | SESE | | [K925892](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K925892.md) | SOLSTICE XRAY RING MARKER PAD | Solstice Corp. | May 18, 1993 | SESE | | [K926404](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K926404.md) | KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L | Eastman Kodak Company | Mar 4, 1993 | SESE | | [K923533](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K923533.md) | ADMARK | Planmeca USA, Inc. | Mar 4, 1993 | SESE | | [K925332](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K925332.md) | BENNETT X-RAY ID PLUS | Bennett X-Ray Technologies | Nov 27, 1992 | SESE | | [K924345](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K924345.md) | RADIOGRAPHIC FILM MARKETING SYSTEM | Fischer Imaging Corp. | Nov 27, 1992 | SESE | | [K920031](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K920031.md) | KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE | Eastman Kodak Company | Feb 12, 1992 | SESE | | [K915088](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K915088.md) | KODAK MIN-R IDENTIFICATION CAMERA | Eastman Kodak Company | Dec 2, 1991 | SESE | | [K913478](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K913478.md) | RADIOGRAPHIC FILM MARKING SYSTEM | Lorad Medical Systems, Inc. | Oct 15, 1991 | SESE | | [K911873](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K911873.md) | X-MARX | Macbrud Corp. Medical Div. | Jul 19, 1991 | SESE | | [K910354](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K910354.md) | DU PONT IDENTIFICATION CAMERA | Dupont Medical Products | Mar 29, 1991 | SESE | | [K890467](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K890467.md) | KODAK PORTABLE IDENTIFICATION CAMERA | Eastman Kodak Company | Feb 16, 1989 | SESE | | [K882519](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K882519.md) | X-RAY MARKER | Karlin Technology, Inc. | Aug 9, 1988 | SESE | | [K870701](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K870701.md) | KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL | Eastman Kodak Company | Feb 26, 1987 | SESE | | [K870565](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K870565.md) | KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L | Eastman Kodak Company | Feb 26, 1987 | SESE | | [K852160](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC/K852160.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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