Atlas FDA

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

Is2 Research, Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time
100 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040057MOBILE COMPACT DIGITAL CARDIAC CAMERAIs2 Research, Inc.2004-02-02200
K033956MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIACIs2 Research, Inc.2004-01-20290
K032779MODIFICATION TO: NUCAMMA RXIs2 Research, Inc.2003-12-171000
K013667BCC GAMMA CAMERAIs2 Research, Inc.2002-01-28830
K003882NUCAMMA BI90Is2 Research, Inc.2001-02-21680
K982045NUCAMMA RXIs2 Research, Inc.1998-09-02840
K982044NUCAMMA R+Is2 Research, Inc.1998-09-02840

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