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

Heidelberg, DE

Medicalcommunications GmbH appears in FDA device records in Heidelberg, DE. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

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

510(k) clearance history

FDA records hold 1 510(k) clearance for Medicalcommunications GmbH in 2020.

Clearances by year, as a table
510(k) clearance decisions for Medicalcommunications GmbH, by decision year
YearClearances
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200132AshvinsLLZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2673-2025Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)Potential that the measured value may be smaller than the actual area.Class IIOpen, Classified

Verification record

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