The following data is part of a premarket notification filed by Blackford Analysis Ltd with the FDA for Blackford Analysis Registration Product Family.
| Device ID | K142337 |
| 510k Number | K142337 |
| Device Name: | Blackford Analysis Registration Product Family |
| Classification | System, Image Processing, Radiological |
| Applicant | BLACKFORD ANALYSIS LTD The Royal Observatory, Blackford Hill Edinburgh, Midlothian, GB Eh9 3hj |
| Contact | Gordon Mcneilly |
| Correspondent | Marion Peat Ardgowan PM Ltd 12/3 Grange Terrance Edinburgh, Midlothian, GB Eh9 2ld |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2015-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060570830044 | K142337 | 000 |
| 05060570830112 | K142337 | 000 |
| 05060570830099 | K142337 | 000 |
| 05060570830105 | K142337 | 000 |
| 05060570830068 | K142337 | 000 |
| 05060570830075 | K142337 | 000 |
| 05060570830082 | K142337 | 000 |
| 05060570830006 | K142337 | 000 |
| 05060570830013 | K142337 | 000 |
| 05060570830037 | K142337 | 000 |
| 05060570830150 | K142337 | 000 |