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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Computed tomographs (CT)
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Computed tomographs - not exceeding 2 layers
Computed tomographs - not exceeding 2 layers
Z11030601
14 devices
Devices
Ingenuity Core 128
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Upgrade Spectral CT SW5.4
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
Ingenuity Core
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Spectral CT Verida RT
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
Spectral CT on Rails
Open recall
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
FDA 510(k)
K203020
Active
Cleared 26 Feb 2021
FDA 510(k)
K212875
Active
Cleared 13 May 2022
+2
authorizations
Spectral CT System Upgrades
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Ingenuity CT System Upgrade
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Spectral CT Verida
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
Spectral CT
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
Ingenuity CT
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
GUDID
on market
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