ClearanceBrief
Company ยท US

Philips North America Llc

FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2021. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
565recalls (102 in 12 months)
513recalls that name a 510(k)

Product codes

CodeDeviceRecords
LNHSystem, Nuclear Magnetic Resonance Imaging236
JAKSystem, X-Ray, Tomography, Computed64
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)46
OWBInterventional Fluoroscopic X-Ray System34
DSIDetector And Alarm, Arrhythmia28
MKJAutomated External Defibrillators (Non-Wearable)27
JAASystem, X-Ray, Fluoroscopic, Image-Intensified23
LNISystem, Nuclear Magnetic Resonance Spectroscopic17
MOSCoil, Magnetic Resonance, Specialty16
DPSElectrocardiograph14
KPSSystem, Tomography, Computed, Emission12
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)9
KPRSystem, X-Ray, Stationary8
DSJAlarm, Blood-Pressure4
IMDPack, Hot Or Cold, Disposable4
HGMSystem, Monitoring, Perinatal3
IZISystem, X-Ray, Angiographic3
HGPElectrode, Circular (Spiral), Scalp And Applicator2
IXRTable, Radiographic, Tilting2
LLZSystem, Image Processing, Radiological2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 11, 2021K203231Switched Internal Paddles
Philips North America, LLC
LDD

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 26, 2026Philips North America
Model Number: 712010.
Open, Classified		 IZLK233678
Oct 16, 2026Philips North America
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Open, Classified		 MHXNone listed
Sep 29, 2026Philips North America Llc
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Open, Classified		 JAKK244008
Sep 25, 2026Philips North America
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Sof
Open, Classified		 LNHK213583
K223458 +2
Sep 25, 2026Philips North America
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK230972
Sep 25, 2026Philips North America
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK213516
Sep 25, 2026Philips North America
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK223458
K251397
Sep 25, 2026Philips North America
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 7821
Open, Classified		 LNHK110151
K213583 +2
Sep 25, 2026Philips North America
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK213516
K223458 +2
Sep 25, 2026Philips North America
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
Open, Classified		 LNHK223442
K223458 +2
Sep 25, 2026Philips North America
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10.
Open, Classified		 LNHK193215
K213516 +4
Sep 25, 2026Philips North America
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 1
Open, Classified		 LNHK183063
K193215 +4
Sep 25, 2026Philips North America
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
Open, Classified		 LNHK183063
K251808
Sep 25, 2026Philips North America
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versi
Open, Classified		 LNHK183063
K193215 +1
Sep 25, 2026Philips North America
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Open, Classified		 LNHK223458
K251397
Sep 18, 2026Philips North America Llc
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (
Open, Classified		 LNHK110151
K193215 +4
Sep 18, 2026Philips North America Llc
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
Open, Classified		 LNHK213516
K230972
Sep 18, 2026Philips North America Llc
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Open, Classified		 LNHK193215
K223442 +1
Sep 18, 2026Philips North America Llc
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Inte
Open, Classified		 LNHK030520
K052013 +1
Sep 18, 2026Philips North America Llc
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
Open, Classified		 LNHK183063
K193215 +4
Sep 18, 2026Philips North America Llc
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Open, Classified		 LNHK183063
K193215 +1
Sep 18, 2026Philips North America Llc
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Open, Classified		 LNHK183063
K193215 +2
Sep 18, 2026Philips North America Llc
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 7812
Open, Classified		 LNHK183063
K193215 +1
Sep 18, 2026Philips North America Llc
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Open, Classified		 LNHK213583
K251808
Sep 18, 2026Philips North America Llc
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Open, Classified		 LNHK052078
Sep 18, 2026Philips North America Llc
Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Open, Classified		 LNHK052013
K052078 +1
Sep 18, 2026Philips North America Llc
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva
Open, Classified		 LNHK052013
K052078 +3
Sep 11, 2026Philips North America
Philips PIC iX Essentials REF:867093
Open, Classified		 MHXK153702
Sep 11, 2026Philips North America
Philips Patient Information Center iX REF:866389
Open, Classified		 MHXK153702
Sep 1, 2026Philips North America Llc
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Open, Classified		 JAKK033326
Sep 1, 2026Philips North America Llc
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Open, Classified		 JAKK160743
Sep 1, 2026Philips North America Llc
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Open, Classified		 JAKK193454
Sep 1, 2026Philips North America Llc
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Open, Classified		 JAKK250648
Aug 14, 2026Philips North America Llc
Cardiac Workstation 7000. Product Number: 860441.
Open, Classified		 DPSK241556
Aug 14, 2026Philips North America Llc
Cardiac Workstation 5000. Product Number: 860439.
Open, Classified		 DPSK241556
Jun 24, 2026Philips North America Llc
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
Open, Classified		 MHXK242962
Jun 22, 2026Philips North America Llc
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Open, Classified		 HGMK140535
Jun 22, 2026Philips North America Llc
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Open, Classified		 HGMK140535
Jun 5, 2026Philips North America Llc
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Open, Classified		 MQBK202564
Apr 27, 2026Philips North America
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Open, Classified		 LNHK213516
K213583 +2
Apr 27, 2026Philips North America
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Open, Classified		 LNHK193215
K213583 +1
Apr 27, 2026Philips North America
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Open, Classified		 LNHK193215
K213583 +2
Apr 27, 2026Philips North America
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Open, Classified		 LNHK213583
Apr 27, 2026Philips North America
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
Open, Classified		 LNHK183063
K193215 +1
Apr 27, 2026Philips North America
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Open, Classified		 LNHK223458
K230972 +1
Apr 27, 2026Philips North America
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972,
Open, Classified		 LNHK213516
K251808
Apr 27, 2026Philips North America
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.
Open, Classified		 LNHK223458
K230972 +2
Apr 27, 2026Philips North America
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
Open, Classified		 LNHK193215
K213583 +3
Apr 27, 2026Philips North America
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Open, Classified		 LNHK193215
K213583
Apr 27, 2026Philips North America
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Open, Classified		 LNHK173079
K251808

Newest 50 of 565.

Get alerts for these product codes