Atlas FDA

INTERA FAMILY

FDA 510(k) clearance K030520 · decided 2003-03-06

Clearance details

K-number
K030520
Device name
INTERA FAMILY
Applicant
Philips Medical Systems North America Co.
Decision
Substantially Equivalent
Date received
2003-02-19
Decision date
2003-03-06
Days to decision
15 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Bothell, WA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System recall (Z-0874-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System recall (Z-0877-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System recall (Z-0878-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System recall (Z-0879-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System recall (Z-0880-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging Sy recall (Z-0881-2019)Philips Medical Systems Nederlands2019-02-22
Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging Sy recall (Z-0883-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System recall (Z-0886-2019)Philips Medical Systems Nederlands2019-02-22
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device recall (Z-1431-2018)Philips Electronics North America Corporation2018-04-18
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for u recall (Z-1432-2018)Philips Electronics North America Corporation2018-04-18
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T recall (Z-1024-2016)Philips Electronics North America Corporation2016-02-26