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

Acoma Medical Imaging, Inc. · Predicate Candidate Screening

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

120 daysmedian FDA review time
160 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981227SYMPHONY 360 REMOTE CONTROL TABLEAcoma Medical Imaging, Inc.1998-06-30880
K981131PATHFINDER MOBILE C ARMAcoma Medical Imaging, Inc.1998-06-26880
K963851TILTING RADIOGRAPHIC TABLE (REMOTE)Acoma Medical Imaging, Inc.1997-01-231200
K944952ANGIOGRAPHIC SYSTEMAcoma Medical Imaging, Inc.1995-02-171330
K941004CTS SYSTEMAcoma Medical Imaging, Inc.1994-07-291500
K941017F/C/W TUBESTANDAcoma Medical Imaging, Inc.1994-07-291480
K925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGERAcoma Medical Imaging, Inc.1993-02-01880
K921116PX-100 PORTABLE X-RAY GENERATORAcoma Medical Imaging, Inc.1992-10-052100
K921425SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-RAcoma Medical Imaging, Inc.1992-08-271560
K902637FUTURUS 2001 X-RAY GENERATORAcoma Medical Imaging, Inc.1990-08-03500
K900562TRANS X 100 CHEST FILM CHANGERAcoma Medical Imaging, Inc.1990-04-10620
K893617MOBILE C-ARMAcoma Medical Imaging, Inc.1989-07-14650
K884345MODEL ESP-200 MAMMOGRAPHIC SYSTEMAcoma Medical Imaging, Inc.1989-03-231600

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