Atlas FDA

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

Siemens Medical Solutions · Predicate Candidate Screening

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

36 daysmedian FDA review time
200 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250738YSIO X.preeSiemens Medical Solutions2025-07-311420
K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions2025-07-141312
K233543YSIO X.preeSiemens Medical Solutions2024-05-212000
K233532MULTIX Impact ESiemens Medical Solutions2023-11-29270
K231577MOBILETT ImpactSiemens Medical Solutions2023-07-25550
K221281Multitom RaxSiemens Medical Solutions2022-11-171981
K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions2022-02-182180
K101749SYNGO TRUED SOFTWARESiemens Medical Solutions2010-08-16550
K081018SYNGO DYNAMICS VERSION 7.0Siemens Medical Solutions2008-04-25150
K071513INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITYSiemens Medical Solutions2007-06-26220
K070629FLEX AND LOOP COIL SET 1.5 TSiemens Medical Solutions2007-03-26190
K061671SYNGO TRUED, MODEL VC10ASiemens Medical Solutions2006-06-29150
K060992SYNGO US WORKPLACESiemens Medical Solutions2006-04-28171
K043030MAGNETOM C! MR SYSTEMSiemens Medical Solutions2004-12-09360
K030657SIEMENS INFINITY GATEWAY SUITE, MODEL VF2Siemens Medical Solutions2003-03-21180

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