LIGHTLINE-M
FDA 510(k) clearance K974240 · decided 1997-12-22
Clearance details
- K-number
- K974240
- Device name
- LIGHTLINE-M
- Applicant
- Wuestec Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-12
- Decision date
- 1997-12-22
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- IZX
- Device class
- 2
- Regulation number
- 892.1610
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mobile, AL, 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 |
|---|---|---|
| RALCO (K110856) | Ralco S.R.L. | 2011-08-10 |
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| SHIMADZU COLLIMATOR R-30H (K031771) | Shimadzu Corp. | 2003-08-21 |
| FACTS MONOBLOCK (K981267) | Dynarad Corp. | 1998-05-06 |
| AXT 150M MANUAL COLLIMATOR (AXT 150M) (K972966) | Applied X-Ray Technologies, Inc. | 1997-08-21 |
| RINN UNIVERSAL COLLIMATOR (K932134) | Rinn Corp. | 1993-07-26 |
| MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (K912180) | Instrumentarium Imaging, Inc. | 1991-10-21 |
| R-100-ET MANUAL COLLIMATOR (K900007) | Advantech | 1990-02-06 |
| R-150-ET COLLIMATOR (K896486) | Advantech | 1990-01-23 |
| COLLI-MATETM MODEL NO. B800 (K874687) | Summit Industries, Inc. | 1987-12-30 |
| COLLIMATOR MODEL A280BLMD & MODEL A280BLMP (K861941) | D&R X-Ray Products, Inc. | 1986-07-25 |
Recalls involving this device
No recalls on record reference this clearance.