MULTI-FORMAT SFD MODEL 1720
FDA 510(k) clearance K800554 · decided 1980-04-10
Clearance details
- K-number
- K800554
- Device name
- MULTI-FORMAT SFD MODEL 1720
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-12
- Decision date
- 1980-04-10
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- IXL
- Device class
- 2
- Regulation number
- 892.1670
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 (K924593) | Philips Medical Systems, Inc. | 1992-11-24 |
| ELITE R/F SPOT FILM DRIVE (K902403) | Rms Div. | 1990-08-01 |
| SFD-035 SPOT FILM DEVICE (K902146) | Rms Div. | 1990-05-31 |
| A.X.T. SPOTFILM DEVICE (K882492) | Applied X-Ray Technologies, Inc. | 1988-07-21 |
| 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (K881589) | Continental X-Ray Corp. | 1988-07-18 |
| SPOT-FILM DEVICE 8835 (K842184) | General Electric Co. | 1984-07-17 |
| RAYTHEON MEDICAL IMAGING (K802888) | Machlett Laboratories, Inc. | 1981-01-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019) | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018) | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016) | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014) | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |