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

Brainlab Med. Computersysteme GmbH — Predicate Candidate Screening

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

256 daysmedian FDA review time
304 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970586BRAINLAB MICRO MULTI-LEAF COLLIMATORBrainlab Med. Computersysteme GmbH1997-05-12871
K954861BRAINLAB CT/X-RAY LOCALIZERBrainlab Med. Computersysteme GmbH1996-08-052870
K952390BRAINLAB STEROTATIC HEADRINGBrainlab Med. Computersysteme GmbH1996-02-022560
K945903BRAINLAB MASK SYSTEMBrainlab Med. Computersysteme GmbH1995-06-051850
K934657BRAINLAB LINAC HARDWAREBrainlab Med. Computersysteme GmbH1994-07-223040

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