# Philips Medical Systems (Cleveland), Inc.

- Location (FDA's records): Cleveland, OH
- FDA decisions: 190 (1977–2017): 190 510(k) clearances
- Product codes: LNH (57), JAK (24), KPS (20), KPR (8), HAW (7), JAA (6), MOS (6), LLZ (5), IZO (5), IXY (4), IYO (4), IZL (4)
- 510(k) review time since 2016: median 133 days, against 96 for FDA's reviews in the same codes and years (1 of 7 faster)
- Predicates its devices cite: 107 (54 its own); citations of its devices by later devices: 147 (54 its own)
- Recalls linked to its devices: 279 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Marconi Medical Systems, Inc.: 8 (https://510kreport.com/company/marconi-medical-systems)
- Philips Medical Systems, Inc.: 7 (https://510kreport.com/company/philips-medical-systems)
- GE Medical Systems: 5 (https://510kreport.com/company/ge-medical-systems)
- Adac Laboratories: 4 (https://510kreport.com/company/adac-laboratories)
- Siemens Medical Solutions USA, Inc.: 4 (https://510kreport.com/company/siemens-medical-solutions-usa)
- GE Healthcare: 3 (https://510kreport.com/company/ge-healthcare)
- Philips Nuclear Medicine, Inc.: 2 (https://510kreport.com/company/philips-nuclear-medicine)
- Medical Advances, Inc.: 2 (https://510kreport.com/company/medical-advances)

## Firms that cite its devices most
- Usa Instruments, Inc.: 10 (https://510kreport.com/company/usa-instruments)
- Philips Medical Systems, Inc.: 9 (https://510kreport.com/company/philips-medical-systems)
- Philips Medical Systems Nederland B.V.: 6 (https://510kreport.com/company/philips-medical-systems-nederland)
- Philips Healthcare (Cleveland): 5 (https://510kreport.com/company/philips-healthcare-cleveland)
- Philips Healthcare (Suzhou) Co., Ltd.: 4 (https://510kreport.com/company/philips-healthcare-suzhou)
- Adac Laboratories: 4 (https://510kreport.com/company/adac-laboratories)
- Us Asia Instruments, Inc.: 4 (https://510kreport.com/company/us-asia-instruments)
- Z-Kat, Inc.: 3 (https://510kreport.com/company/z-kat)

## Its most-cited devices
- K945827: Outlook (1995), cited by 8
- K060937: Brilliance Volume (2006), cited by 8
- K923851: Acqsim Simulator/Localizer (1992), cited by 7
- K052640: Gemini Raptor (2005), cited by 6
- K970604: Viewpoint - 3.0 Software (1997), cited by 6
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner (2004), cited by 6

## Recent decisions
- K171850: Philips CT Big Bore (Nov 9, 2017)
- K172406: Ingenuity TF (Oct 6, 2017)
- K162838: Philips iCT CT System (Apr 7, 2017)
- K163711: IQon Spectral CT (Apr 5, 2017)
- K170086: Pinnacle Radiation Therapy Planning System (Feb 9, 2017)
- K160743: Philips Ingenuity CT (Aug 8, 2016)
- K153444: Philips Multislice CT System with Low Dose CT Lung Cancer (Apr 8, 2016)
- K130992: PINNACLE3 Radiation Therapy Planning System (Jun 14, 2013)

Source page: https://510kreport.com/company/philips-medical-systems-cleveland