510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Stephanix

La Ricamarie Auvergne-Rhone-Alpes, FR

Stephanix appears in FDA device records in La Ricamarie Auvergne-Rhone-Alpes, FR. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Stephanix between 2021 and 2022. The busiest year on record is 2021, with 2. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Stephanix, by decision year
YearClearances
20212
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221335D²RS and D²RS 9090OWBSubstantially Equivalent
K213479D²RS and D²RS 9090OWBSubstantially Equivalent
K212515MOVIX DReamyIZLSubstantially Equivalent

Registered establishments

FDA registered establishments for Stephanix, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30069727523006972752Stephanix10 Rue Jean Moulin, La Ricamarie Auvergne-Rhone-Alpes 42150 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0557-2019STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.Class IITerminated

Verification record

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