Atlas FDA

IXK

14 FDA 510(k) clearances · Product code

102 daysmedian time to decision
398 days90th percentile
14clearances measured

FDA profile

Official device name
System, Imaging, X-Ray, Electrostatic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1630
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1 · 1994: 2 · 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA (K093640)Electron Jsco.2011-04-29
PVMED DDR 2520 DIGITAL IMAGING SYSTEM (K072766)Portavision Medical2007-12-11
RADIOTHERAPY SOLUTION BASED ON CR (K042779)Agfa Corp.2004-10-21
PORT CASSETTE (K032654)Orex Computed Radiography, Ltd.2003-10-09
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (K003689)Canon USA, Inc.2002-01-02
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (K000159)Agfa Corp.2000-02-16
FUJI FCR IMAGE PROCESSING UNIT IP-U515 (K942561)Fujifilm Medical System U.S.A., Inc.1994-12-23
DIGORA (K934949)Orion Corporation Soredex1994-02-10
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (K931002)Fujifilm Medical System U.S.A., Inc.1993-06-08
DIGISCAN 2 (K924459)Siemens Medical Solutions USA, Inc.1992-12-17
FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (K923990)Fujifilm Medical System U.S.A., Inc.1992-12-17
FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGE (K924012)Fujifilm Medical System U.S.A., Inc.1992-10-16
XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEM (K853459)Xerox Medical Systems1985-10-30
XERORADIOGRAPHY 125 SYSTEM - MODIFIED (K761022)Xeroradiography1976-11-24

Track IXK automatically

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