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

Fischer Imaging Corp. — Predicate Candidate Screening

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

66 daysmedian FDA review time

170 days90th percentile

69clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K042095	MAMMOTEST	Fischer Imaging Corp.	2004-10-29	87	1
K021113	MAMMOPATH	Fischer Imaging Corp.	2002-06-13	69	0
K981414	LC POSITIONER	Fischer Imaging Corp.	1998-07-16	87	0
K973400	MAMMOTEST ADAPTER DRIVER	Fischer Imaging Corp.	1997-11-10	62	0
K964806	MD-1835	Fischer Imaging Corp.	1997-03-04	95	0
K961207	EP-X BIPLANE	Fischer Imaging Corp.	1996-08-20	146	3
K961022	TANGENT VI TABLE	Fischer Imaging Corp.	1996-05-03	50	0
K945619	ATHENA HFX	Fischer Imaging Corp.	1995-03-23	128	0
K950291	DIGITAL 625HF	Fischer Imaging Corp.	1995-03-23	57	0
K944149	MICRO X-80 HF	Fischer Imaging Corp.	1994-09-16	22	0
K944147	MICRO X-50 HF	Fischer Imaging Corp.	1994-09-16	22	0
K944148	MICRO X-30HF	Fischer Imaging Corp.	1994-09-16	22	0
K944150	MICRO X-65 HF	Fischer Imaging Corp.	1994-09-16	22	0
K943504	RSX-525HF	Fischer Imaging Corp.	1994-08-17	28	0
K926560	EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER	Fischer Imaging Corp.	1994-05-09	494	0
K934481	EP-X	Fischer Imaging Corp.	1993-11-03	50	3
K930792	RSX 30HF	Fischer Imaging Corp.	1993-05-19	92	0
K926575	MAMMOTEST PRODUCT, MODIFICATION	Fischer Imaging Corp.	1993-03-30	119	0
K924137	CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)	Fischer Imaging Corp.	1992-12-28	132	0
K924345	RADIOGRAPHIC FILM MARKETING SYSTEM	Fischer Imaging Corp.	1992-11-27	92	0
K914748	COMET C-125	Fischer Imaging Corp.	1992-10-15	359	0
K922454	MOBILE ATHENA HF	Fischer Imaging Corp.	1992-09-11	108	0
K923061	MAMMOSCAN	Fischer Imaging Corp.	1992-09-10	77	0
K915853	TANGENT V	Fischer Imaging Corp.	1992-01-24	28	0
K915199	STORZ IMAGING SYSTEM	Fischer Imaging Corp.	1992-01-23	65	0
K915592	PEGASUS LATERAL CARDIAC POSITIONER	Fischer Imaging Corp.	1992-01-13	31	0
K905694	FVP-1000 FAMILY AND FVP-1000D FAMILY	Fischer Imaging Corp.	1991-11-27	343	0
K914266	MICRO-X 30 HF	Fischer Imaging Corp.	1991-11-27	65	0
K914236	MICRO-X 50 HF	Fischer Imaging Corp.	1991-11-27	68	0
K912741	ELITE R 90/15	Fischer Imaging Corp.	1991-10-04	105	0
K910647	XIMATRON/CT OPTION	Fischer Imaging Corp.	1991-09-19	218	0
K912449	MICRO-X 15 HF	Fischer Imaging Corp.	1991-08-28	86	0
K912448	CSP	Fischer Imaging Corp.	1991-08-28	86	3
K912586	TANGENT IV	Fischer Imaging Corp.	1991-08-02	51	0
K905695	MICRO-X 80HF	Fischer Imaging Corp.	1991-03-06	77	0
K905501	ELITE 5000	Fischer Imaging Corp.	1991-01-18	42	0
K900989	ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM	Fischer Imaging Corp.	1990-03-28	26	0
K900234	PFM-90 CEILING TUBE SUPPORT	Fischer Imaging Corp.	1990-02-26	40	0
K894913	DA-100HS	Fischer Imaging Corp.	1989-09-18	47	0
K893673	RMS 180	Fischer Imaging Corp.	1989-07-20	66	0
K893674	RME 325R	Fischer Imaging Corp.	1989-07-20	66	0
K893653	RADIOGRAPHIC CEILING TUBE SUPPORT CTS15	Fischer Imaging Corp.	1989-06-23	39	0
K893652	RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60	Fischer Imaging Corp.	1989-06-23	39	0
K884292	STRETCHER TABLE	Fischer Imaging Corp.	1989-03-31	170	0
K885127	SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM	Fischer Imaging Corp.	1989-02-16	66	0
K883976	CFX 625	Fischer Imaging Corp.	1988-12-13	84	0
K883831	IMAGER	Fischer Imaging Corp.	1988-11-21	73	0
K883985	CARDIAC CX	Fischer Imaging Corp.	1988-11-21	62	0
K883860	ADVANTAGE	Fischer Imaging Corp.	1988-11-21	69	0
K884134	MICRO-X 100CP	Fischer Imaging Corp.	1988-10-21	21	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