← Product Code [IXX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX) · K850421

# CINE RADIOGRAPHIC FILM PROCESSOR M-45CR (K850421)

_The Allen Products Co. · IXX · Mar 22, 1985 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX/K850421

## Device Facts

- **Applicant:** The Allen Products Co.
- **Product Code:** [IXX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX.md)
- **Decision Date:** Mar 22, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1900
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

## Special Controls

*Classification.* Class II (special 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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX/K850421](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXX/K850421)

**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