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

Sopha Medical Systems, Inc. · Predicate Candidate Screening

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

126 daysmedian FDA review time

254 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K952190	TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE	Sopha Medical Systems, Inc.	1996-01-18	254	0
K942837	DST-XL	Sopha Medical Systems, Inc.	1995-01-05	204	2
K921008	VECTOR SERIES	Sopha Medical Systems, Inc.	1992-04-27	55	0
K913641	SOPHY NXT	Sopha Medical Systems, Inc.	1991-12-17	126	0
K911346	SOPHYCAMERA DSX BODYTRAK	Sopha Medical Systems, Inc.	1991-04-18	22	1
K894931	SOPHYCAMERA DSX RECTANGULAR	Sopha Medical Systems, Inc.	1989-10-27	86	1
K872132	SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS	Sopha Medical Systems, Inc.	1987-10-26	145	0
K872297	DS-7 NUCLEAR MEDICINE GAMMA CAMERA	Sopha Medical Systems, Inc.	1987-08-12	57	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