510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OANClass II

Orthosis, Cranial, Laser Scan

21 CFR 882.5970 / Neurology
FDA source (opens on fda.gov)

OAN is the FDA product code for Orthosis, Cranial, Laser Scan, a class II device type, regulated under 21 CFR 882.5970. FDA's definition for this code reads: "A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with...". As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OAN
Device name
Orthosis, Cranial, Laser Scan
FDA definition
A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Regulation
21 CFR 882.5970
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
0

Clearances, product code OAN

By decision year
23 clearances under product code OAN with a decision year between 2001 and 2025, 2008 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code OAN by decision year
YearClearances
20011
20023
20071
20085
20092
20131
20141
20153
20161
20181
20212
20241
20251

Applicants with the most clearances

Product code OAN
Applicants holding the most 510(k) clearances under product code OAN
ApplicantClearances
Orthomerica Products, Inc.17
Boston Brace Intl., Inc.2
Cranial Technologies, Inc.2
Biosculptor Corporation1
Hanger Prosthetics & Orthotics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code