Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1670](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1670) → IXL — Device, Spot-Film

# IXL · Device, Spot-Film

_Radiology · 21 CFR 892.1670 · Class 2_

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

## Overview

- **Product Code:** IXL
- **Device Name:** Device, Spot-Film
- **Regulation:** [21 CFR 892.1670](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1670)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K111304](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K111304.md) | OPTIMA XR120 | Ge Medical Systems, LLC | Jul 19, 2011 | SESE |
| [K964806](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K964806.md) | MD-1835 | Fischer Imaging Corp. | Mar 4, 1997 | SESE |
| [K950317](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K950317.md) | ADVANTX 1824 SPOTFILM DEVICE | GE Medical Systems | Feb 8, 1995 | SESE |
| [K940386](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K940386.md) | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | Eastman Kodak Company | Aug 17, 1994 | SESE |
| [K942367](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K942367.md) | AXT 1400 SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | Jun 6, 1994 | SESE |
| [K924593](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K924593.md) | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 | Philips Medical Systems, Inc. | Nov 24, 1992 | SESE |
| [K902403](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K902403.md) | ELITE R/F SPOT FILM DRIVE | Rms Div. | Aug 1, 1990 | SESE |
| [K902146](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K902146.md) | SFD-035 SPOT FILM DEVICE | Rms Div. | May 31, 1990 | SESE |
| [K882492](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K882492.md) | A.X.T. SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | Jul 21, 1988 | SESE |
| [K881589](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K881589.md) | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 | Continental X-Ray Corp. | Jul 18, 1988 | SESE |
| [K842184](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K842184.md) | SPOT-FILM DEVICE 8835 | General Electric Co. | Jul 17, 1984 | SESE |
| [K802888](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K802888.md) | RAYTHEON MEDICAL IMAGING | Machlett Laboratories, Inc. | Jan 9, 1981 | SESE |
| [K800554](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IXL/K800554.md) | MULTI-FORMAT SFD MODEL 1720 | Philips Medical Systems (Cleveland), Inc. | Apr 10, 1980 | SESE |

## Top Applicants

- Rms Div. — 2 clearances
- Applied X-Ray Technologies, Inc. — 2 clearances
- Philips Medical Systems, Inc. — 1 clearance
- Philips Medical Systems (Cleveland), Inc. — 1 clearance
- Machlett Laboratories, Inc. — 1 clearance

---

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

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