CATHETERIZATION TABLE KS-60
FDA 510(k) clearance K951315 · decided 1995-05-11
Clearance details
- K-number
- K951315
- Device name
- CATHETERIZATION TABLE KS-60
- Applicant
- Shimadzu Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1995-03-23
- Decision date
- 1995-05-11
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- IZZ
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE (K971452) | Siemens Medical Solutions USA, Inc. | 1997-05-14 |
| MED-TRON SPECT IMAGING TABLE (K952701) | Med-Tron Products, Inc. | 1995-07-06 |
| ANGIOREX CAT-350B (K951053) | Toshiba America Medical Systems, In.C | 1995-04-06 |
| RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE (K943926) | Philips Medical Systems (Cleveland), Inc. | 1994-11-28 |
| ALPHA (K930273) | Raymax Medical Corp. | 1993-07-13 |
| B-4 FOUR-WAY RADIOGRAPHIC TABLE (K924444) | Control-X, Inc. | 1993-02-05 |
| SHIMADZU RADIOGRAPHIC TABLE BK-100 (K925174) | Shimadzu Medical Systems | 1992-11-27 |
| DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004 (K921501) | Biodan Medical Systems, Ltd. | 1992-05-15 |
| CATHERIZATION KS-50 (K920732) | Shimadzu Medical Systems | 1992-04-16 |
| CAT-250B (K915413) | Toshiba America Medical Systems, In.C | 1991-12-19 |
| CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111 (K912516) | Continental X-Ray Corp. | 1991-11-19 |
| CLASSIC 4-WAY ELEVATING TABLE (K912474) | Continental X-Ray Corp. | 1991-09-16 |
Recalls involving this device
No recalls on record reference this clearance.