Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1840](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1840) → IWZ — Film, Radiographic # IWZ · Film, Radiographic _Radiology · 21 CFR 892.1840 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ ## Overview - **Product Code:** IWZ - **Device Name:** Film, Radiographic - **Regulation:** [21 CFR 892.1840](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1840) - **Device Class:** 1 - **Review Panel:** [Radiology](/submissions/RA) ## Identification Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures. ## 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 (20 of 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K970154](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K970154.md) | KODAK EKTASIAN HG FILM (EHG-15) | Eastman Kodak Company | Apr 4, 1997 | SESE | | [K954200](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K954200.md) | VOXGRAM | Voxel | Sep 29, 1995 | SESE | | [K931604](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K931604.md) | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | 3M Health Care, Ltd. | Jul 21, 1993 | SESE | | [K931605](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K931605.md) | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | 3M Health Care, Ltd. | Jul 20, 1993 | SESE | | [K920539](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K920539.md) | ORWO X-RAY FILM | Burkhart Roentgen Intl., Inc. | Jun 30, 1992 | SESE | | [K884827](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K884827.md) | KODAK DENTAL BARRIER PAC | Eastman Kodak Company | Jan 30, 1989 | SESE | | [K862944](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K862944.md) | KODAK CFT FILM SO-141 | Eastman Kodak Company | Aug 12, 1986 | SESE | | [K862415](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K862415.md) | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Parexel Intl. Corp. | Jul 1, 1986 | SESE | | [K860797](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K860797.md) | MEDICAL X-RAY FILM | India-America Trading Co. | Mar 13, 1986 | SESE | | [K844554](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K844554.md) | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | Belmont Equipment Corp. | Feb 21, 1985 | SESE | | [K840806](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K840806.md) | FR MEDICAL X-RAY FILM | Fr Medical/Fr Chemicals | Apr 24, 1984 | SESE | | [K840698](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K840698.md) | POWERMAT VRP-1 X-RAY IMAGING | Powers Chemco, Inc. | Mar 16, 1984 | SESE | | [K834614](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K834614.md) | WILCOR-XR RP-L MEDICAL FILM | Cea America Corp. | Mar 5, 1984 | SESE | | [K834613](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K834613.md) | WILCOR-XR RP MEDICAL FILM | Cea America Corp. | Mar 5, 1984 | SESE | | [K834612](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K834612.md) | WILCOR-XR RP-OG MEDICAL FILM | Cea America Corp. | Feb 27, 1984 | SESE | | [K834611](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K834611.md) | SINGUL-XR RP NON SCREEN MED. FILM | Cea America Corp. | Feb 21, 1984 | SESE | | [K833234](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K833234.md) | KODAK T-MAT L FILM SO-387 | Eastman Kodak Company | Oct 28, 1983 | SESE | | [K832504](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K832504.md) | CRONEX LO-DOSE MAMMOGRAPHY | E.I. Dupont DE Nemours & Co., Inc. | Sep 12, 1983 | SESE | | [K813005](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K813005.md) | KODAK CINEFLUOROGRAPHIC FILM SO-274 | Eastman Kodak Company | Nov 24, 1981 | SESE | | [K811352](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ/K811352.md) | POLAROID TPX RADIOGRAPHIC FILM | Polaroid Corp. | Jun 18, 1981 | SESE | ## Top Applicants - Eastman Kodak Company — 17 clearances - Cea America Corp. — 4 clearances - 3M Health Care, Ltd. — 2 clearances - E.I. Dupont DE Nemours & Co., Inc. — 2 clearances - Belmont Equipment Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IWZ) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com