Atlas FDA

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

Medicatech USA — Predicate Candidate Screening

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

92 daysmedian FDA review time
151 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230918MasterX 800 SeriesMedicatech USA2023-09-011510
K190601MasteRad MX30Medicatech USA2019-04-25480
K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary RadiMedicatech USA2015-02-06850
K130377KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT Medicatech USA2013-05-17920
K112132KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMMedicatech USA2011-11-181150
K102285KRYSTALRAD (ATAL8)Medicatech USA2011-01-031440
K102284KRYSTALRAD 560 (FLAATZ 560)Medicatech USA2011-01-031440
K082798DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AMedicatech USA2008-10-28350
K080582MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100Medicatech USA2008-05-15730

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