Atlas FDA

IZF

42 FDA 510(k) clearances · Product code

59 daysmedian time to decision
183 days90th percentile
42clearances measured

FDA profile

Official device name
System, X-Ray, Tomographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1740
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 2 · 2000: 1 · 2001: 1 · 2010: 6 · 2011: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TAP2D (K252649)Nano-X Imaging , Ltd.2026-02-02
Adaptix Ortho350 (K252133)Adaptix Limited2025-11-06
Nanox.ARC X (K250850)Nano-X Imaging , Ltd.2025-04-16
Nanox.ARC (K242395)Nano-X Imaging , Ltd.2024-12-04
Nanox.ARC (K222934)Nano-X Imaging , Ltd.2023-04-28
Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949)Pausch Medical GmbH2023-01-26
CLISIS SYSTEMS, Discovery RF180 (K213081)General Medical Merate S.P.A2021-10-26
DR 600 with Tomosynthesis (K193262)Agfa N.V.2020-03-09
DR 800 with Tomosynthesis (K183275)Agfa N.V.2019-02-01
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261)Ge Medical Systems, LLC2013-11-18
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (K121499)Fujifilm Medical System U.S.A., Inc.2012-11-20
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION (K013620)Medstone Intl., Inc.2002-01-22
PROGNOST ES, MODEL 0302 0000 (K011290)Xmar Corp.2001-05-30
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO (K973864)Pausch Corp.1998-06-17
CS2000 & CS2000 TOMO (K973834)Pausch Corp.1998-04-30
LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 (K950571)Continental X-Ray Corp.1995-03-31
BENNETT X-RAY TOMOGRAPHY SYSTEM (K945749)Bennett X-Ray Corp.1995-02-15
TOMO-LINK (K944967)GE Medical Systems1994-12-09
LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 (K942175)Continental X-Ray Corp.1994-08-17
2000 X-RAY - TOMOGRAPHIC (K931815)Imaging Sciences Intl., Inc.1993-08-23
RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE (K924443)Control-X, Inc.1993-02-05
PHILIPS INTEGRIS H/HM SYSTEM (K925302)Philips Medical Systems, Inc.1992-12-17
TOMAX ULTRASCAN (K892653)Incubation Industries, Inc.1989-08-28
ORTHORALIX SD/ORTHORALIX SD CEPH (K890351)Philips Medical Systems North America, Inc.1989-06-15
RESUBMITTED SCANORA (K884650)Orion Corp.1989-03-16
ORALIX PANORAMIC D.C. (K852768)Philips Medical Systems, Inc.1985-09-19
DIGITILT LS-30 REMOTE CONTROL (K834288)Elscint, Inc.1983-12-29
SOMATOM 2N (K811302)Siemens Corp.1981-06-23
SUPERIX 120 (K811197)Tecnomed, Inc.1981-06-09
CLINIX-R TOMOGRAPHIC DEVICE (K810274)Philips Medical Systems (Cleveland), Inc.1981-03-11
ZONOGRAPH 6 (K810307)Siemens Corp.1981-03-11
INTEGRON (K792327)Tecnomed, Inc.1979-12-20
VTX (GE CATAOLG NO. B7005A) (K792067)General Electric Co.1979-12-10
MULTIGRAPH (K790765)Siemens Corp.1979-04-26
TECNOTOMO (K790132)Teknomed, Inc.1979-02-21
OPTIPLANIMAT (K781531)Siemens Corp.1978-09-14
COMPUTERIZED AXIAL TOMOGRAPHY (K780995)Emi Medical, Inc.1978-06-22
ORBITOME-UG (K780319)Philips Medical Systems (Cleveland), Inc.1978-03-14
VERSATOME (K771549)Kermath Mfg. Corp.1977-08-25
TUBE CONVEYOR MODEL DS-PB-4 (K771296)Toshiba Medical Systems1977-08-03
TUBESTAND MODEL DS-TA-4 (K771297)Toshiba Medical Systems1977-08-03
X-RAY SCANNER, WHOLE BODY, AS&E (K761004)American Science and Engineering, Inc.1976-12-16

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Every clearance here is in the API, with alerts when new ones post.