Atlas FDA

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

IXK — Predicate Candidate Screening

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

102 daysmedian FDA review time
398 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K093640DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAElectron Jsco.2011-04-295210
K072766PVMED DDR 2520 DIGITAL IMAGING SYSTEMPortavision Medical2007-12-11740
K042779RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.2004-10-21150
K032654PORT CASSETTEOrex Computed Radiography, Ltd.2003-10-09420
K003689CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.2002-01-023980
K000159AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOAgfa Corp.2000-02-16280
K942561FUJI FCR IMAGE PROCESSING UNIT IP-U515Fujifilm Medical System U.S.A., Inc.1994-12-232060
K934949DIGORAOrion Corporation Soredex1994-02-101150
K931002FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONSFujifilm Medical System U.S.A., Inc.1993-06-081020
K924459DIGISCAN 2Siemens Medical Solutions USA, Inc.1992-12-171060
K923990FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGEFujifilm Medical System U.S.A., Inc.1992-12-171290
K924012FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGEFujifilm Medical System U.S.A., Inc.1992-10-16670
K853459XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEMXerox Medical Systems1985-10-30750
K761022XERORADIOGRAPHY 125 SYSTEM - MODIFIEDXeroradiography1976-11-24130

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