ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
FDA 510(k) clearance K052078 · decided 2005-09-07
Clearance details
- K-number
- K052078
- Device name
- ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
- Applicant
- Philips Medical Systems Nederland B.V.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-01
- Decision date
- 2005-09-07
- Days to decision
- 37 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
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philip recall (Z-0505-2024) | Philips North America Llc | 2023-12-14 |
| Achieva 1.5T recall (Z-0389-2024) | Philips North America Llc | 2023-11-21 |
| Achieva 1.5T Conversion recall (Z-0390-2024) | Philips North America Llc | 2023-11-21 |
| Ingenia 1.5T CX recall (Z-0392-2024) | Philips North America Llc | 2023-11-21 |
| Intera 1.5T recall (Z-0393-2024) | Philips North America Llc | 2023-11-21 |
| Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System recall (Z-0875-2019) | Philips Medical Systems Nederlands | 2019-02-22 |
| Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System recall (Z-0876-2019) | Philips Medical Systems Nederlands | 2019-02-22 |
| Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS recall (Z-1307-2015) | Philips Medical Systems, Inc. | 2015-03-20 |