IXL
13 FDA 510(k) clearances · Product code
53 daysmedian time to decision
96 days90th percentile
13clearances measured
FDA profile
- Official device name
- Device, Spot-Film
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1670
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1998: 5 · 2001: 1 · 2003: 2 · 2004: 2 · 2006: 2 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OPTIMA XR120 (K111304) | Ge Medical Systems, LLC | 2011-07-19 |
| MD-1835 (K964806) | Fischer Imaging Corp. | 1997-03-04 |
| ADVANTX 1824 SPOTFILM DEVICE (K950317) | GE Medical Systems | 1995-02-08 |
| KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP (K940386) | Eastman Kodak Company | 1994-08-17 |
| AXT 1400 SPOTFILM DEVICE (K942367) | Applied X-Ray Technologies, Inc. | 1994-06-06 |
| DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (K924593) | Philips Medical Systems, Inc. | 1992-11-24 |
| ELITE R/F SPOT FILM DRIVE (K902403) | Rms Div. | 1990-08-01 |
| SFD-035 SPOT FILM DEVICE (K902146) | Rms Div. | 1990-05-31 |
| A.X.T. SPOTFILM DEVICE (K882492) | Applied X-Ray Technologies, Inc. | 1988-07-21 |
| 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (K881589) | Continental X-Ray Corp. | 1988-07-18 |
| SPOT-FILM DEVICE 8835 (K842184) | General Electric Co. | 1984-07-17 |
| RAYTHEON MEDICAL IMAGING (K802888) | Machlett Laboratories, Inc. | 1981-01-09 |
| MULTI-FORMAT SFD MODEL 1720 (K800554) | Philips Medical Systems (Cleveland), Inc. | 1980-04-10 |
Track IXL automatically
Every clearance here is in the API, with alerts when new ones post.