Atlas FDA

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

Pie Medical · Predicate Candidate Screening

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

57 daysmedian FDA review time
98 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K061961ART LAB SOFTWAREPie Medical2006-09-06570
K053154MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEMPie Medical2005-12-16320
K043588MYLAB 15 / MYLAB 20, MODEL 2700Pie Medical2005-01-25280
K043360IMT.LABPie Medical2005-01-05290
K041675PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSPie Medical2004-07-23320
K033604TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50LPie Medical2003-12-15280
K023512PICUS ULTRASOUND IMAGING SYSTEMSPie Medical2003-01-24950
K02011250S TRINGA ULTRASOUND IMAGING SYSTEMPie Medical2002-04-19980
K003725240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUSPie Medical2001-03-01870
K003292260 CORVUSPie Medical2001-01-05770
K002357100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMSPie Medical2000-11-09990
K002880300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LCPie Medical2000-10-26410

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