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

Cgr Medical Corp. — Predicate Candidate Screening

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

44 daysmedian FDA review time

92 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K843926	PRESTILIX 1690	Cgr Medical Corp.	1984-12-17	51
K843235	STENOSCOP	Cgr Medical Corp.	1984-11-08	84
K843985	SUSPENSION 7	Cgr Medical Corp.	1984-11-05	25
K841649	MAXIMAX - 4	Cgr Medical Corp.	1984-06-05	46
K833223	SONEL 3000A	Cgr Medical Corp.	1984-05-09	244
K833941	ORION	Cgr Medical Corp.	1983-12-29	44
K834306	PHASIX-HIGH FREQUENCY GENERATOR	Cgr Medical Corp.	1983-12-29	55
K833846	PROCESS 100 ST	Cgr Medical Corp.	1983-12-16	92
K837412	SATURNE I LINEAR ACCELERATOR	Cgr Medical Corp.	1983-06-28	68
K837465	ALCYON ROTATIONAL COBALT THERAPY	Cgr Medical Corp.	1983-06-28	56
K837336	VERASUN RADIATION THERAPY SIMULATION SYSTEM	Cgr Medical Corp.	1983-04-29	30
K827489	HYPERLUX 30 IMAGE SYSTEM	Cgr Medical Corp.	1982-11-04	0
K813051	COMPTAR III	Cgr Medical Corp.	1981-11-24	26
K812963	IBIS II	Cgr Medical Corp.	1981-11-24	33
K812238	D.I.V.A.S.	Cgr Medical Corp.	1981-09-11	31
K811723	WHOLE BODY SCANNER	Cgr Medical Corp.	1981-07-20	32
K810945	SCANEL 100	Cgr Medical Corp.	1981-05-08	31
K802704	SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.	Cgr Medical Corp.	1980-12-11	41
K801844	SONIA-SO NOGRAPH-NUMERICAL ANALYSIS	Cgr Medical Corp.	1980-10-03	63
K781040	CT SCANNER ND 8000	Cgr Medical Corp.	1978-07-18	28

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