Device, Spot-Film
A spot-film device is an accessory component used with fluoroscopic systems to enable rapid acquisition of radiographic spot images during fluoroscopic examinations, allowing the capture of static images at selected moments during dynamic studies. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IXL, regulated under 21 CFR 892.1670, within the Radiology medical specialty.
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Basic Information
- Product Code
- IXL
- Device Class
- FDA class 2
- Regulation Number
- 892.1670
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111304 | OPTIMA XR120 | Jul 19, 2011 | Substantially Equivalent | Ge Medical Systems, LLC |
| K964806 | MD-1835 | Mar 04, 1997 | Substantially Equivalent | Fischer Imaging Corp. |
| K950317 | ADVANTX 1824 SPOTFILM DEVICE | Feb 08, 1995 | Substantially Equivalent | GE Medical Systems |
| K940386 | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | Aug 17, 1994 | Substantially Equivalent | Eastman Kodak Company |
| K942367 | AXT 1400 SPOTFILM DEVICE | Jun 06, 1994 | Substantially Equivalent | Applied X-Ray Technologies, Inc. |
| K924593 | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 | Nov 24, 1992 | Substantially Equivalent | Philips Medical Systems, Inc. |
| K902403 | ELITE R/F SPOT FILM DRIVE | Aug 01, 1990 | Substantially Equivalent | Rms Div. |
| K902146 | SFD-035 SPOT FILM DEVICE | May 31, 1990 | Substantially Equivalent | Rms Div. |
| K882492 | A.X.T. SPOTFILM DEVICE | Jul 21, 1988 | Substantially Equivalent | Applied X-Ray Technologies, Inc. |
| K881589 | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 | Jul 18, 1988 | Substantially Equivalent | Continental X-Ray Corp. |
| K842184 | SPOT-FILM DEVICE 8835 | Jul 17, 1984 | Substantially Equivalent | General Electric Co. |
| K802888 | RAYTHEON MEDICAL IMAGING | Jan 09, 1981 | Substantially Equivalent | Machlett Laboratories, Inc. |
| K800554 | MULTI-FORMAT SFD MODEL 1720 | Apr 10, 1980 | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.