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

Afp Imaging Corp. — Predicate Candidate Screening

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

76 daysmedian FDA review time
157 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEMAfp Imaging Corp.2012-12-27510
K072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEMAfp Imaging Corp.2007-09-18270
K041120EV APAN DIGITAL, MODEL K1VSM2000Afp Imaging Corp.2004-08-301230
K030647EVA DIGITAL DENTAL X-RAY SYSTEMAfp Imaging Corp.2003-03-20200
K014144EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804Afp Imaging Corp.2002-02-07510
K013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWAREAfp Imaging Corp.2001-10-16220
K974619SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEMAfp Imaging Corp.1998-02-25760
K950288AUTOLASER MULTI FORMAT CAMERAAfp Imaging Corp.1995-04-04690
K925885AFP 17 X 4 AUTOMATIC FILM PROCESSORAfp Imaging Corp.1993-06-092050
K930761IMAGE-X 70 INTRAORAL X-RAY SYSTEMAfp Imaging Corp.1993-05-251020
K925684OLYMP-X,X-RAY GENERATORAfp Imaging Corp.1993-02-02820
K922443VERT-X UNIVERSAL VERTICAL BUCKY STANDAfp Imaging Corp.1992-10-261570
K843917FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTLAfp Imaging Corp.1985-01-03900

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