Atlas FDA

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

Scott Imaging Intl., Inc. · Predicate Candidate Screening

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

64 daysmedian FDA review time
108 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K946260NTBS-1417, 1436, TBS-1417Scott Imaging Intl., Inc.1995-03-311080
K950040SII 525 APRScott Imaging Intl., Inc.1995-03-21750
K950041SII 360 APRScott Imaging Intl., Inc.1995-03-21750
K946261MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5Scott Imaging Intl., Inc.1995-02-15640
K946262EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLESScott Imaging Intl., Inc.1995-02-15640
K945709SII 525 MSScott Imaging Intl., Inc.1994-12-14230
K945708SII 360 MSScott Imaging Intl., Inc.1994-12-14230

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