JWM
17 FDA 510(k) clearances · Product code
52 daysmedian time to decision
195 days90th percentile
17clearances measured
FDA profile
- Official device name
- System, Tomographic, Nuclear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1310
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1 · 1997: 4 · 1998: 4 · 1999: 4 · 2000: 4 · 2001: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Every clearance here is in the API, with alerts when new ones post.