IXL · Device, Spot-Film
Radiology · 21 CFR 892.1670 · Class 2
Overview
| Product Code | IXL |
|---|---|
| Device Name | Device, Spot-Film |
| Regulation | 21 CFR 892.1670 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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 | OPTIMA XR120 | Ge Medical Systems, LLC | Jul 19, 2011 | SESE |
| K964806 | MD-1835 | Fischer Imaging Corp. | Mar 4, 1997 | SESE |
| K950317 | ADVANTX 1824 SPOTFILM DEVICE | GE Medical Systems | Feb 8, 1995 | SESE |
| K940386 | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | Eastman Kodak Company | Aug 17, 1994 | SESE |
| K942367 | AXT 1400 SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | Jun 6, 1994 | SESE |
| K924593 | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 | Philips Medical Systems, Inc. | Nov 24, 1992 | SESE |
| K902403 | ELITE R/F SPOT FILM DRIVE | Rms Div. | Aug 1, 1990 | SESE |
| K902146 | SFD-035 SPOT FILM DEVICE | Rms Div. | May 31, 1990 | SESE |
| K882492 | A.X.T. SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | Jul 21, 1988 | SESE |
| K881589 | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 | Continental X-Ray Corp. | Jul 18, 1988 | SESE |
| K842184 | SPOT-FILM DEVICE 8835 | General Electric Co. | Jul 17, 1984 | SESE |
| K802888 | RAYTHEON MEDICAL IMAGING | Machlett Laboratories, Inc. | Jan 9, 1981 | SESE |
| K800554 | 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
