Atlas FDA

IYZ

12 FDA 510(k) clearances · Product code

71 daysmedian time to decision
97 days90th percentile
12clearances measured

FDA profile

Official device name
Bed, Scanning, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1350
Medical specialty
Radiology
Adverse events (MAUDE)
1992: 3 · 1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MULTIPLE ACCESSORY TO GAMMA CAMERAS (K920962)Nu Age Products1992-04-17
SPECT TABLE, MODEL #056-760 (K915541)Atomic Products Corp.1992-01-17
XYZ CRANK IMAGING TABLE (K911691)Med-Tron Products, Inc.1991-08-09
ECT CARBON FIBER PALLET, MODIFICATION (K912481)Siemens Gammasonics, Inc.1991-08-02
CARDIAC SPECT PALLET (K912286)Siemens Gammasonics, Inc.1991-08-02
E-Z LIFT CRANK IMAGING TABLE (K912181)Med-Tron Products, Inc.1991-07-17
XY IMAGING TABLE (K912135)Med-Tron Products, Inc.1991-07-17
E-Z LIFT IMAGING TABLE WITH FOOT PUMP (K911564)Med-Tron Products, Inc.1991-07-15
XYZ IMAGING TABLE WITH FOOT PUMP (K911561)Med-Tron Products, Inc.1991-07-15
SCANNING COT (K903901)Med-Tron Products, Inc.1990-09-21
ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL (K903767)Siemens Gammasonics, Inc.1990-09-07
QRSYSTEMS H.D. NUCLEAR IMAGING TABLE (K893826)Qrsystems, Inc.1989-08-02

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Every clearance here is in the API, with alerts when new ones post.