Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Invivo Corporation · Predicate Candidate Screening

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

49 daysmedian FDA review time

118 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWris	Invivo Corporation	2021-12-23	22	0
K212227	Philips MR Patient Care Portal	Invivo Corporation	2021-09-30	76	1
K212175	DynaCAD	Invivo Corporation	2021-08-02	21	0
K193403	UroNav System	Invivo Corporation	2019-12-27	21	0
K192200	DynaCAD	Invivo Corporation	2019-10-09	57	0
K182561	UroNav (Version 3.0)	Invivo Corporation	2018-10-19	31	0
K162177	dS FootAnkle I6CH 1.5T Coil	Invivo Corporation	2016-09-14	41	0
K162001	1.5T and 3.0T 16 CH GE Shoulder Coils	Invivo Corporation	2016-08-31	42	0
K152330	Expression MR400 MRI Patient Monitoring System	Invivo Corporation	2015-12-23	127	0
K153073	UroNav (Version 2.0)	Invivo Corporation	2015-11-16	25	0
K133030	DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)	Invivo Corporation	2014-01-22	118	1
K132359	MRI PATIENT MONITORING SYSTEM	Invivo Corporation	2013-08-30	31	0
K131382	EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION I	Invivo Corporation	2013-07-15	62	3
K124061	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	Invivo Corporation	2013-02-22	53	1
K122897	SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SEN	Invivo Corporation	2012-12-21	91	0
K122646	DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T	Invivo Corporation	2012-11-02	64	0
K121424	EXPRESSION INFORMATION PORTAL	Invivo Corporation	2012-06-13	30	3
K120122	SENSE MSK S 8CH 1.5T	Invivo Corporation	2012-02-10	24	0
K111673	1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL	Invivo Corporation	2011-12-23	191	0
K103700	ESSENTIAL MRI PATIENT MONITOR	Invivo Corporation	2011-03-15	85	0
K103149	1.5T 16-CHANNEL HAND-WRIST COIL	Invivo Corporation	2011-01-03	70	0
K093842	1.5T AND 3.0T GENERAL PURPOSE FLEX COILS	Invivo Corporation	2010-03-05	80	0
K093284	1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL	Invivo Corporation	2010-02-01	104	1
K081262	DC NEURO	Invivo Corporation	2008-06-17	43	0
K062767	CTL-63 AND CTL-128 SPINE ARRAY COILS	Invivo Corporation	2006-10-13	28	0
K062144	ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810	Invivo Corporation	2006-10-12	77	0
K061675	VISION VXC CENTRAL STATION, MODEL 4300	Invivo Corporation	2006-08-02	49	0
K053462	3160 MRI PATIENT MONITORING SYSTEM	Invivo Corporation	2006-01-18	36	2
K053017	MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS	Invivo Corporation	2005-11-16	21	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