510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Quantib B.V.

Rotterdam, NL

Quantib B.V. appears in FDA device records in Rotterdam, NL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Quantib B.V. between 2016 and 2026. The busiest year on record is 2018, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Quantib B.V., by decision year
YearClearances
20161
20171
20182
20202
20222
20231
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253682DeepHealth ProstateAIQDQSubstantially Equivalent
K251527Brain WMHQIHSubstantially Equivalent
K230772Quantib ProstateLLZSubstantially Equivalent
K221106Quantib ProstateLLZSubstantially Equivalent
K213737Quantib NDLLZSubstantially Equivalent
K202501Quantib ProstateLLZSubstantially Equivalent
K200899Quantib AI NodeLLZSubstantially Equivalent
K182564Quantib NDLLZSubstantially Equivalent
K173939Quantib BrainLLZSubstantially Equivalent
K163013Quantib Brain 1.2LLZSubstantially Equivalent
K153351Quantib Brain 1LLZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Quantib B.V. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Quantib B.V.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain