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

Siemens Corp. — Predicate Candidate Screening

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

34 daysmedian FDA review time

87 days90th percentile

66clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K103360	DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL	Siemens Corp.	2010-12-17	31	0
K993947	KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE	Siemens Corp.	1999-12-21	29	0
K992925	AX WORKSTATION DR-VIEWER SOFTWARE OPTION	Siemens Corp.	1999-11-23	85	0
K991652	HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM	Siemens Corp.	1999-08-03	82	0
K991600	SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION	Siemens Corp.	1999-06-09	30	0
K984221	FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR	Siemens Corp.	1999-02-12	79	0
K984224	PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS	Siemens Corp.	1999-02-02	69	0
K982536	PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE	Siemens Corp.	1998-11-24	126	0
K963983	E. CAM PROFILE ATTENUATION CORRECTION	Siemens Corp.	1997-03-31	178	0
K941546	SOMATOM PROJECT 059	Siemens Corp.	1994-09-20	173	0
K942116	SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)	Siemens Corp.	1994-07-29	87	0
K822978	MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3	Siemens Corp.	1982-12-15	68	0
K822983	MINGOCARD 7 & MINGOPHONE 7	Siemens Corp.	1982-11-24	47	0
K820112	SIEMENS POLYDOROS 800	Siemens Corp.	1982-02-24	40	0
K820111	SIEMENS SIRESKOP 4	Siemens Corp.	1982-02-18	34	0
K812610	SIEMENS-ELEMA PULSE GENERATOR 668 B	Siemens Corp.	1981-12-10	86	0
K812104	SIEMENS-ELEMA PSA 376	Siemens Corp.	1981-12-02	131	0
K812721	DIGITRON	Siemens Corp.	1981-11-04	37	0
K812616	POLYPHOS 500	Siemens Corp.	1981-10-13	28	0
K811807	UROSKOP C	Siemens Corp.	1981-08-10	46	0
K811587	SIEMENS ANGIOTRON	Siemens Corp.	1981-07-10	35	0
K811302	SOMATOM 2N	Siemens Corp.	1981-06-23	43	0
K811149	PANDOROS 1200A	Siemens Corp.	1981-06-09	43	0
K803208	SIRECUST 358	Siemens Corp.	1981-05-27	160	0
K810858	XIMATRON V	Siemens Corp.	1981-05-13	44	0
K810307	ZONOGRAPH 6	Siemens Corp.	1981-03-11	34	0
K810190	OPTI 110/12/50HSG	Siemens Corp.	1981-03-02	38	0
K810189	SIRECON COMPACT	Siemens Corp.	1981-03-02	38	0
K810191	SIRCAM 103	Siemens Corp.	1981-02-26	34	0
K803130	MULTIX U. BUCKY TABLE X-RAY UNIT	Siemens Corp.	1981-01-28	47	1
K803124	SIDOS U.	Siemens Corp.	1981-01-22	42	0
K802200	VERTIX 3D-U	Siemens Corp.	1980-10-23	42	1
K802296	MINGOGRAF EEG10	Siemens Corp.	1980-10-03	14	0
K802292	MINGOGRAF EEG21	Siemens Corp.	1980-10-03	14	0
K801723	UR 150-UR 150T	Siemens Corp.	1980-08-13	20	0
K800593	SIRECUST 311S	Siemens Corp.	1980-04-02	16	0
K800172	SIROPORT	Siemens Corp.	1980-02-05	11	0
K792645	TRIOSKOP	Siemens Corp.	1980-01-28	33	0
K792535	PORTARAY	Siemens Corp.	1980-01-28	52	0
K792392	POLYPHOS	Siemens Corp.	1979-12-20	24	0
K792393	GIGANTOS 1012 MP	Siemens Corp.	1979-12-20	24	0
K792394	SIRCAM 106	Siemens Corp.	1979-12-20	24	0
K790975	SOMATOM 2	Siemens Corp.	1979-07-30	68	0
K791214	TRIDOROS 712	Siemens Corp.	1979-07-30	28	0
K790783	KOORDINAT 3D	Siemens Corp.	1979-05-07	14	0
K790765	MULTIGRAPH	Siemens Corp.	1979-04-26	7	1
K790681	SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150	Siemens Corp.	1979-04-13	3	0
K790342	SOMATOM SD	Siemens Corp.	1979-03-22	29	0
K790359	HALOTHANE VAPORIZER 950, & ENFLURANE 951	Siemens Corp.	1979-03-21	27	0
K790069	BUCKYMAT	Siemens Corp.	1979-01-26	14	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