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

Summit Nuclear — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

139 daysmedian FDA review time

171 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K935273	VISION FX 40 & 80 SERIES GAMMA CAMERA	Summit Nuclear	1994-04-18	167	2
K935318	SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS	Summit Nuclear	1994-02-25	113	0
K922427	SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM	Summit Nuclear	1992-09-29	130	0
K922426	SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM	Summit Nuclear	1992-09-28	129	0
K920958	SUMMIT NUCLEAR VISION NEUROSPECT	Summit Nuclear	1992-08-07	171	0
K912573	VISION (NUCLEAR MEDICINE COMPUTER)	Summit Nuclear	1991-10-28	139	0

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