Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

IYZ — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

71 daysmedian FDA review time

97 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K920962	MULTIPLE ACCESSORY TO GAMMA CAMERAS	Nu Age Products	1992-04-17	74
K915541	SPECT TABLE, MODEL #056-760	Atomic Products Corp.	1992-01-17	38
K911691	XYZ CRANK IMAGING TABLE	Med-Tron Products, Inc.	1991-08-09	115
K912481	ECT CARBON FIBER PALLET, MODIFICATION	Siemens Gammasonics, Inc.	1991-08-02	71
K912286	CARDIAC SPECT PALLET	Siemens Gammasonics, Inc.	1991-08-02	71
K912181	E-Z LIFT CRANK IMAGING TABLE	Med-Tron Products, Inc.	1991-07-17	62
K912135	XY IMAGING TABLE	Med-Tron Products, Inc.	1991-07-17	64
K911564	E-Z LIFT IMAGING TABLE WITH FOOT PUMP	Med-Tron Products, Inc.	1991-07-15	97
K911561	XYZ IMAGING TABLE WITH FOOT PUMP	Med-Tron Products, Inc.	1991-07-15	97
K903901	SCANNING COT	Med-Tron Products, Inc.	1990-09-21	29
K903767	ECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PAL	Siemens Gammasonics, Inc.	1990-09-07	18
K893826	QRSYSTEMS H.D. NUCLEAR IMAGING TABLE	Qrsystems, Inc.	1989-08-02	70

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda