Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

IZF — Predicate Candidate Screening

42 FDA 510(k) clearances under this product code; the 50 most recent screened below.

59 daysmedian FDA review time

183 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252649	TAP2D	Nano-X Imaging , Ltd.	2026-02-02	165	0
K252133	Adaptix Ortho350	Adaptix Limited	2025-11-06	122	0
K250850	Nanox.ARC X	Nano-X Imaging , Ltd.	2025-04-16	27	0
K242395	Nanox.ARC	Nano-X Imaging , Ltd.	2024-12-04	113	0
K222934	Nanox.ARC	Nano-X Imaging , Ltd.	2023-04-28	214	0
K221949	Ortho Device, ADAPTIX 3D Orthopedic Imaging System	Pausch Medical GmbH	2023-01-26	205	0
K213081	CLISIS SYSTEMS, Discovery RF180	General Medical Merate S.P.A	2021-10-26	33	0
K193262	DR 600 with Tomosynthesis	Agfa N.V.	2020-03-09	104	0
K183275	DR 800 with Tomosynthesis	Agfa N.V.	2019-02-01	70	2
K132261	DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)	Ge Medical Systems, LLC	2013-11-18	122	1
K121499	FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY	Fujifilm Medical System U.S.A., Inc.	2012-11-20	183	0
K013620	MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION	Medstone Intl., Inc.	2002-01-22	78	0
K011290	PROGNOST ES, MODEL 0302 0000	Xmar Corp.	2001-05-30	33	0
K973864	COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO	Pausch Corp.	1998-06-17	251	0
K973834	CS2000 & CS2000 TOMO	Pausch Corp.	1998-04-30	204	0
K950571	LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270	Continental X-Ray Corp.	1995-03-31	59	0
K945749	BENNETT X-RAY TOMOGRAPHY SYSTEM	Bennett X-Ray Corp.	1995-02-15	84	0
K944967	TOMO-LINK	GE Medical Systems	1994-12-09	59	0
K942175	LINEAR TOMOGRAPHIC SYSTEM: PMT 6000	Continental X-Ray Corp.	1994-08-17	105	0
K931815	2000 X-RAY - TOMOGRAPHIC	Imaging Sciences Intl., Inc.	1993-08-23	137	0
K924443	RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE	Control-X, Inc.	1993-02-05	157	0
K925302	PHILIPS INTEGRIS H/HM SYSTEM	Philips Medical Systems, Inc.	1992-12-17	57	5
K892653	TOMAX ULTRASCAN	Incubation Industries, Inc.	1989-08-28	137	0
K890351	ORTHORALIX SD/ORTHORALIX SD CEPH	Philips Medical Systems North America, Inc.	1989-06-15	142	0
K884650	RESUBMITTED SCANORA	Orion Corp.	1989-03-16	129	0
K852768	ORALIX PANORAMIC D.C.	Philips Medical Systems, Inc.	1985-09-19	83	0
K834288	DIGITILT LS-30 REMOTE CONTROL	Elscint, Inc.	1983-12-29	31	0
K811302	SOMATOM 2N	Siemens Corp.	1981-06-23	43	0
K811197	SUPERIX 120	Tecnomed, Inc.	1981-06-09	40	0
K810274	CLINIX-R TOMOGRAPHIC DEVICE	Philips Medical Systems (Cleveland), Inc.	1981-03-11	37	0
K810307	ZONOGRAPH 6	Siemens Corp.	1981-03-11	34	0
K792327	INTEGRON	Tecnomed, Inc.	1979-12-20	31	0
K792067	VTX (GE CATAOLG NO. B7005A)	General Electric Co.	1979-12-10	56	0
K790765	MULTIGRAPH	Siemens Corp.	1979-04-26	7	1
K790132	TECNOTOMO	Teknomed, Inc.	1979-02-21	29	0
K781531	OPTIPLANIMAT	Siemens Corp.	1978-09-14	8	0
K780995	COMPUTERIZED AXIAL TOMOGRAPHY	Emi Medical, Inc.	1978-06-22	8	0
K780319	ORBITOME-UG	Philips Medical Systems (Cleveland), Inc.	1978-03-14	18	0
K771549	VERSATOME	Kermath Mfg. Corp.	1977-08-25	13	0
K771296	TUBE CONVEYOR MODEL DS-PB-4	Toshiba Medical Systems	1977-08-03	55	0
K771297	TUBESTAND MODEL DS-TA-4	Toshiba Medical Systems	1977-08-03	55	0
K761004	X-RAY SCANNER, WHOLE BODY, AS&E	American Science and Engineering, Inc.	1976-12-16	38	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