ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
FDA 510(k) clearance K063559 · decided 2007-01-04
Clearance details
- K-number
- K063559
- Device name
- ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2006-11-27
- Decision date
- 2007-01-04
- Days to decision
- 38 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
+ Add to Predicate Builder ◉ Watch Philips Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for recall (Z-1855-2024) | Philips North America Llc | 2024-05-17 |
| 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 |
| Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5 recall (Z-0325-2016) | Philips Medical Systems, Inc. | 2015-11-23 |
| 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Ach recall (Z-0971-2009) | Invivo Corporation | 2009-02-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |