Atlas FDA

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

Aktina Medical Physics Corp. · Predicate Candidate Screening

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

84 daysmedian FDA review time
92 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103616PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZERAktina Medical Physics Corp.2011-01-25460
K081935STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100Aktina Medical Physics Corp.2008-10-07920
K040709PROTOS SOFTWAREAktina Medical Physics Corp.2004-04-28410
K032248PRECISE CARBON FIBER TABLE TOP, MODEL 11-999Aktina Medical Physics Corp.2003-09-25650
K014081AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGESAktina Medical Physics Corp.2002-03-05840
K003330AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINAAktina Medical Physics Corp.2001-01-04720
K993522AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERTAktina Medical Physics Corp.2000-01-10840
K991546AKTINA MEDICAL PHYSICS CORPORATION TILT BOARDAktina Medical Physics Corp.1999-07-30880
K990997AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTERAktina Medical Physics Corp.1999-06-22890
K974239AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTAktina Medical Physics Corp.1998-02-10900
K973953AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPINAktina Medical Physics Corp.1998-01-14900
K970384VELOS CONSTANCY CHECK DEVICE, MODEL 55-145Aktina Medical Physics Corp.1997-07-291760
K964840BEAM BLOCK TRAYSAktina Medical Physics Corp.1997-02-11740

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