510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Philips Medical Systems Technologies Ltd.

Ramat Gan Tel Aviv, IL

Philips Medical Systems Technologies Ltd. appears in FDA device records in Ramat Gan Tel Aviv, IL. FDA records list 5 510(k) clearances between and , no PMA records and 4 registered establishments. 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
5
PMA records
0
Recall records
1
Registered establishments
4

510(k) clearance history

FDA records hold 5 510(k) clearances for Philips Medical Systems Technologies Ltd. between 2018 and 2026. The busiest year on record is 2024, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Philips Medical Systems Technologies Ltd., by decision year
YearClearances
20181
20242
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253649Spectral CT Verida FamilyJAKSubstantially Equivalent
K244008Spectral CTJAKSubstantially Equivalent
K240844Spectral CT 7500 RTJAKSubstantially Equivalent
K240822Image Management V15LLZSubstantially Equivalent
K173588Illumeo SystemLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Philips Medical Systems Technologies Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96179783008581796PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.ADVANCED TECHNOLOGY CENTER, HAIFA 3100202 IL2026
30106564003010656400Philips Medical Systems Technologies LtdHaChilazon 5 st., Ramat Gan Tel Aviv 5252269 IL2026
30157636553015763655Philips Medical Systems Technologies Ltd.MATAM, Building 34, Haifa 3100202 IL2026
96814753006303679Philips Medical Systems Technologies Ltd.2 Hapnina Street, P.O. Box 46, Raanana Central 4321538 IL2026

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-0497-2025Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.Class IIOpen, Classified

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